1- H pylori Management summary.pdf

Arab Republic of Egypt Evidence-based clinical practice guidelines for diagnosis and treatment of H pylori related diseases in children and adolescent  EVIDENCE-BASEDCLINICAL PRACTICE GUIDELINES For the diagnosis and treatment of H pylori related di...

Arab Republic of Egypt Evidence-based clinical practice guidelines for diagnosis and treatment of H pylori related diseases in children and adolescent  EVIDENCE-BASEDCLINICAL PRACTICE GUIDELINES For the diagnosis and treatment of H pylori related diseases in children and adolescent FIRST EDITION August 2021 Adapted from the source guidelines 1. The updated JSPGHAN guidelines for the management of Helicobacter pylori infection in childhood.Pediatrics International (2020) 62, 1315–1331 2. Joint ESPGHAN/NASPGHAN Guidelines for theManagement of Helicobacter pylori in Children andAdolescents (Update 2016) -2-  Authorship group (the Authors) & Editorial Board Names Affiliations Gastroenterology team 1. Suzan Samir Gad (moderator) MD, Suez Canal University 2. Ahmed Foad MD, Alexandria University 3. Ahmed Hamdy MD, Ain Shams University 4. Amal Mahfouz MD, Alexandria University 5. Ayman Emil Eskandr MD, Cairo University 6. Gihan Bebars MD, Minia University 7. HalaHussien Mansour MD, Cairo University 8. Hanan Fathy MD, Cairo University 9. MahaAbouZekri MD, Cairo University 10. Mohamed Ezz MD, Mansoura University 11. Naglaa Abu Faddan MD, Assuit University 12. Sara Tarek MD, Cairo University Methodology Supervision Group Ashraf Abdel Baky Chair of EPG Prof. of Pediatrics, Ain Shams University Tarek Omar MD, Alexandria University Yasser Sami Amer MD, Alexandria University Printed in Cairo, Egypt in 2021 Introduction and background Helicobacter pylori (H. pylori) is one of the most common bacterial infections worldwide1. It is a Gram-negative microaerophilic bacteria colonises the gastric mucosa2, The prevalence of infection in pediatric age is high and varies from country to country. 3 In Egypt, the overall H. pylori prevalence was 72.38%. and the burden of H. pylori infection -3- is high in rural areas than in urban areas (82.5%).4&5 Its main risk factor is residing in an overcrowded home and socially deprived area1. Seroprevalence of H. pylori was significantly age-dependent: 60.6% of patients aged more than 5 years and 25.9% of patients aged less than 5 years.6 The infection is acquired during childhood, usually through a household contact, and in most cases persists through adulthood.7 The most frequent form of disease in children is chronic gastritis, and complications are rare during childhood. 8 Most infected children are asymptomatic. There is no evidence of an association between infection by H. pylori with chronic abdominal pain compatible with functional disorders as noted in the Rome IV criteria. However, ulcers associated with H. pylori infection may cause abdominal pain and upper gastrointestinal bleeding, which is the main indication for diagnostic testing for H. pylori infection.3 The development of the disease is related to the virulence of the strain, the genetic predisposition, the host’s immune response, the time of exposure and environmental factors. 9&10 There is evidence of an association between H. pylori infection and many extra-gastroduodenal diseases. With the exception of refractory iron-deficiency anemia, or mucosa-associated lymphoid tissue (MALT) lymphoma, the presence of another disease is not sufficient indication for testing for H. pylori11&12. Several diagnostic tests for detection of H. pylori have been widely used in clinical practice. These diagnostic methods may be classified as invasive, which require endoscopy to obtain biopsies of gastric tissues, and non-invasive. The invasive methods include histological examination, culture, urease test and molecular methods, while the non- invasive methods include urea breath testing, serology and stool antigen testing. 13,14&15 Diagnosis in children requires the use of invasive methods with endoscopy. Non- invasive assessment methods are reserved to determine whether H. pylori has been eradicated.7 The test and treat strategy involve delivery of H. pylori eradication therapy based on positive results of a non-invasive test, such as the H. pylori breath test or stool antigen test. This strategy is commonly used in the management of adults cannot be extrapolated to the pediatric population. This practice has resulted in a significant increase in the prevalence of H. pylori resistant to the antibiotics commonly used for its eradication.16 After confirmation of symptomatic H pylori infection, treatment should be started.Treatments targeting H. pylori infection consist of combinations of a Proton pump -4- inhibitors and several antimicrobial agents. Therapy should be guided by antibiotic resistance profiles. Culture with sensitivities can guide treatment. Treatment should provide adequate doses of medication for 14 days. 17 The recommended goal for H pylori treatment is an eradication rate of at least 90% to avoid further investigations and antibiotic use. Confirmation of eradication should be performed in all patients due to increased antibiotic resistance. 1 Health Questions used to develop this Adapted CPGL 1. What are the GI symptoms which highly suspected of H. pylori related diseases in children? 2. What endoscopic findings are especially recommended for H. pylori tests for children who underwent upper gastrointestinal endoscopy for abdominal symptoms or anemia? 3. Which tests are recommended for the diagnosis of H. pylori infection in children? 4. What are the uses of non-invasive? (1) The 13C-UBT. (2) A 2-step monoclonal stool H pylori antigen test? 5. Is diagnostic testing for H. pylori‐infection recommended in children with functional abdominal pain? 6. Is diagnostic testing for H. pylori‐infection recommended in children with iron def anemia? 7. Is diagnostic testing for H. pylori‐infection recommended in children with refractory iron def anemia? 8. Is diagnostic testing for H. pylori‐infection recommended in children with chronic ITP? 9. Is diagnostic testing for H. pylori‐infection recommended children with short stature? 10. Is diagnostic testing for H. pylori‐infection recommended for asymptomatic children to protect gastric cancer development? 11. Is diagnostic testing for H. pylori‐infection recommended for asymptomatic children living in the household of infected adult? 12. Who should be treated? -5- 13. Is eradication therapy recommended in H. pylori-infected children with gastric MALT lymphoma.? 14. Is eradication therapy recommended in H. pylori-infected children with chronic idiopathic urticaria? 15. Is eradication therapy recommended If H pylori is an incidental finding at endoscopy? 16. Is eradication therapy recommended in H. pylori-infected children who have a family history of gastric cancer in their first- or second-degree relatives? 17. Which eradication regimens are recommended as the first‐line therapies for H. pylori infection in children? 18. What is the duration of therapy? 19. Which eradication regimens are recommended as the second‐line therapies in H. pylori‐infected children in whom the first‐line therapy failed? 20. Is a combination of probiotics with triple therapy eradication regimens effective for H. pylori treatment in children? 21. What kinds of adverse effects associated with eradication therapy should be considered? 22. When should we perform H. pylori testing to determine whether eradication of H. pylori was successful? 23. What are the tests used to determine whether H pylori treatment was successful? 24. Which diagnostic test for H. pylori is recommended to determine whether eradication of H. pylori was successful? 25. Is endoscopic biopsy needed to confirm eradication of infection? 26. Are serological tests needed to confirm eradication of infection? this cut-off date. -6-  Recommendations Key Recommendations Health Recommendation Level of evidence questions 1-What are H. pylori related diseases in children including chronic the GI gastritis, gastric and/or duodenal ulcers. GI symptoms Strength of recommendation: symptoms which highly suspected of H. pylori related diseases in Strong. Evidence which children are epigastric pain or tenderness on level: A. Agreement: 100%. highly examination, nausea, emesis, hematemesis, and suspected melena- or guaiac-positive stools. of H. pylori Refractory IDA and Chronic ITP related diseases in children? JESPGHA N Page 3 1A. What are the non-GIT symptoms that may be related to H. pylori related diseases in children? -7- 1B- We recommend that testing for H pylori be performed GRADE: Strong ESPGHAN in children with gastric or duodenal PUD. If H pylori recommendation. Page 4 infection is identified then treatment should be Quality of administered and eradication confirmed. evidence: high. Agreement: 100%. 2-What Strong. Evidence We recommend H. pylori tests when the following endoscopic level: C. endoscopic findings are observed at diagnostic upper findings Agreement: 100% endoscopy: antrum‐predominant nodularity, are Japanese ulcerations or erosions in the stomach or duodenum especially and / or disappearance of regular arrangement of recommen collecting venules (RAC) in the gastric body. ded for H. pylori tests for children who underwent upper gastrointest inal endoscopy for abdominal symptoms or anemia? 3-Which Strong We recommend that the diagnosis of H pylori infection tests are recommendation. should be based on either (a) histopathology (H pylori– recommen Quality of positive gastritis) plus at least 1 other positive biopsy- ded for the evidence: high. based test or (b) positive culture. diagnosis Agreement: 100%. of H. 3A.We recommend considering the performance of a ESPGHAN -8- pylori infec rapid urease test directly on gastric biopsies to tion in determine presence / absence of H. pylori as a children? diagnostic test for active infection. Weak. Evidence japanese level: C. 3B.We recommend histological examination of gastric Agreement: 100%. biopsies as a biopsy‐based diagnostic test for active H. Japanese pylori infection. 3C.We recommend H. pylori culture because the Weak. Evidence culture method is the gold standard biopsy‐based test level: B. for active infection and it can also be used for Agreement: 100%. antimicrobial susceptibility testing for optimization of Japanese eradication therapy. Strong. Evidence level: Not 3D. We recommend that at least 6 gastric biopsies applicable. should be obtained for the diagnosis of H pylori Agreement: infection during upper endoscopy. 100%.japanese Quality of evidence: low. Agreement: 93%. ESPGHAN 4-What are Strong We recommend against a ‘‘test and treat’’ strategy for the uses of recommendation. H pylori infection in children non- Quality of invasive? We recommend against antibody-based tests evidence: low (1) The (immunoglobulin G [IgG], IgA) for H pylori in serum, (indirect). 13C-UBT. whole blood, urine, and saliva in the clinical setting Agreement: 100% (2) A 2- step monoclona Strong l stool H recommendation. -9- pylori Quality of antigen evidence: high. test. Agreement: 86%. ESPGHAN Is We recommend against diagnostic testing for H pylori GRADE: Strong diagnostic infection in children with functional abdominal pain recommendation. testing disorders. Quality of for H. evidence: high. pylori‐infe Agreement: 100%. ction recommen ded in children with functional abdominal pain Is We recommend against diagnostic testing for H pylori GRADE: Strong diagnostic infection as part of the initial investigation in children recommendation. testing with iron deficiency anemia (IDA). Quality of for H. evidence: pylori‐infe moderate. ction Agreement: 93%. recommen ded in children with iron def anemia - 10 - Is We suggest that in children with refractory IDA in GRADE: Weak diagnostic which other causes have been ruled out, testing forH recommendation. testing pylori during upper endoscopy may be considered. Quality of for H. evidence: pylori‐infe low. Agreement: ction 100%. recommen ded in children with refractory iron def anemia Is We suggest that noninvasive diagnostic testing for H GRADE: Weak diagnostic pylori infection may be considered when investigating recommendation. testing causes of chronic immune thrombocytopenic Quality of for H. purpura (ITP) evidence: pylori‐infe low. Agreement: ction 93%. recommen ded in children with chronic ITP Is We recommend against diagnostic testing for H pylori GRADE: strong diagnostic infection when investigating causes of short stature. recommendation. testing Quality of for H. evidence: pylori‐infe moderate. - 11 - ction Agreement: 79% recommen ded children with short stature? Is We recommend against a “test-and treat” strategy for Strength of diagnostic H. pylori infection for asymptomatic children to recommendation: testing protect gastric cancer development Not determined. for H. Evidence pylori‐infe level: C. ction Agreement: 100%. recommen ded for asymptoma tic childrento protect gastric cancer developme nt? Is We recommend against a “test-and treat” strategy for Strength of diagnostic asymptomatic children living in the household of an H. recommendation: testing pylori-infected adult who received eradication therapy Weak. Evidence for H. to prevent re-infection in that adult. level: B. pylori‐infe Agreement: 100% ction recommen ded for asymptoma tic children - 12 - living in the household of infected adult? - Who Weak. Evidence Eradication therapy should be considered for children, should be level: C. 5 years of age or more, determined to be infected treated? Agreement: with H. pylori by a test for active infection, taking 92%.Japanese account possible re‐infection. We recommend eradication therapy for H. pylori‐infected children with gastric and/or duodenal Strong. Evidence ulcers. level: A. Agreement:100%.J We recommend consideration of eradication therapy apanese for H. pylori‐infected children who underwent Weak. Evidence diagnostic upper gastrointestinal endoscopy for level: D. abdominal symptoms. Agreement: 100%.Japanese. We recommend consideration of eradication therapy Weak. Evidence for H. pylori‐infected children with histological level: B. evidence of chronic gastritis, in the absence of ulcers, Agreement: 100%. to improve mucosal inflammation in the stomach. Japanese. We recommend eradication therapy for H. Strong. Evidence pylori‐infected children with IDA when the iron level: A. deficiency is recurrent or refractory to iron supplement Agreement: 100% therapy. Japanese. We recommend eradication therapy for H. pylori‐infected children with chronic ITP as the Strong. Evidence first‐line therapy. level: B. Agreement: 100% - 13 -  Japanese.. 3B To confirm eradication, we recommend that before GRADE: Strong Precautions testing for H pylori, wait at least 2 weeks after recommendation. of stool stopping PPIs and 4 weeks after stopping antibiotics. Quality of antigen? evidence: ESPGHAN low. Agreement: Page 6 100%. Is We recommend eradication therapy for H. pylori- Strength of eradication infected children with gastric MALT lymphoma. recommendation: therapy Strong. Evidence recommen level: B. ded in H. Agreement: 100%. pylori- infected children with gastric MALT lymphoma. ? Is We do not recommend eradication therapies for H. Strength of eradication pylori-infected children with chronic idiopathic recommendation: therapy urticaria. Not determined. recommen. Evidence ded in H. level: C. pylori- Agreement: Not infected reached children with - 14 - chronic idiopathic urticaria? Is If H pylori is an incidental finding at endoscopy Weak eradication treatment may be considered following careful recommendation therapy discussion of the risks and benefits of H pylori recommen treatment with the patient/parents. When H pylori is ded If H detected by biopsy-based methods in absence of PUD, pylori is an treatment may be considered incidental finding at endoscopy ? Is We recommend consideration of eradication Strength of eradication therapies for children who have a family history of recommendation: therapy gastric cancer in their first- or second-degree relatives Weak. Evidence recommen and in whom active H. pylori infection has been found. level: B. ded in H. Agreement: 100%. pylori- infected childrenwh o have a family history of gastric cancer in their first- or second- degree relatives? 1- A proton pump inhibitor- based triple regimen Strength of - 15 - Which with amoxicillin and clarithromycin as the first- recommendation: eradication line therapy if H. pylori strains are susceptible Strong. regimens to clarithromycin or the antimicrobial Evidence level: D. are susceptibility of the strains is unknown. Agreement: 100%. recommen 2- a proton pump inhibitor- based triple regimen ded as the with amoxicillin and metronidazole as the first- first‐line line therapy, if H. pylori strains are shown to be therapies resistant to clarithromycin. for H. pylori infec tion in children? JESPGHA max. daily N dose dosage per day mg/kg/day mg/d (twice per day) ay proton pump inhibitors lansoprazo le 1.5 60 omeprazol e 1 40 rabeprazol e 0.5 20 >4 years BW30kg ole 40mg/kg/day 40 antibiotics amoxicillin 50 1500 clarithromy cin 15-20 800 metronidaz ole 10--20 500 What is the Regarding the duration of eradiation regimen in Strength of duration of children, a 7-day course of treatment regimen is recommendation: therapy? basically recommended. However, if clinicians judge Strong. that there is a therapeutic need according to individual Evidence level: B. risk of eradication failure, then the eradication regimen Agreement: 100%. should be employed as a longer duration regimen for - 16 -  up to 14 days. Which second-line therapies in H. pylori-infected children in Strength of eradication whom the first-line therapy failed recommendation: regimens 1-a proton pump inhibitor- based triple regimen Strong. are with amoxicillin and metronidazole was shown to Evidence level: D. recommen be successful in children who failed in eradicating Agreement: 100%. ded as the H. pylori with clarithromycin containing triple second‐line therapy. therapies 2- In patients with second-line eradication failure, in H. antimicrobial susceptibility should be obtained pylori‐infe for the infecting H. pylori strain and salvage cted therapy should be tailored accordingly children in whom the first‐line therapy failed? Is a Improvement of the eradication rate by a combination Strength of combinatio of probiotics is not clear. However, it has been shown recommendation: n of to be effective for the prevention of side effects Not applicable. probiotics including diarrhea. Evidence with triple level: C. therapy Agreement: Not eradication applicable regimens effective for H. pylori treat ment in children? What kinds Individual side-effect such as diarrhea, nausea, Strength of of adverse vomiting, dyspepsia or dysphagia, which occurred with recommendation: - 17 - effects the conventional eradication therapy, significantly Not applicable. associated decreased by combining with probiotics Evidence level: C. with Agreement: Not eradication applicable. therapy should be considered When We recommend that the outcome of anti–H pylori strong should we therapy be assessed at least 4 weeks after completion recommendation. perform H. of therapy. Quality of pylori testi evidence: ng to moderate. determine Agreement: 100%. whether eradication of H. pylori was successful? What are We recommend that one of the following tests be used Strong the tests to determine whether H pylori treatment was recommendation. used to successful: Quality of determine (1) The 13C-UBT. evidence: whether H (2) A 2-step monoclonal stool H pylori antigen test. high. Agreement: pylori 93%. ESPGHAN treatment was successful? JAPANES We recommend that the 13C-urea breath test or stool Strength of page 9 antigen ELISA test using a monoclonal antibody be recommendation: Which employed to confirm eradication Strong. Evidence diagnostic level: A. - 18 - test for H. Agreement: 100%. pylori is recommen ded to determine whether eradication of H. pylori was successful? Is We recommend against H. pylori tests using Strength of endoscopic endoscopic biopsy specimens (rapid urease test, recommendation: biopsy histological examination, and the culture method) to Not determined. needed to confirm the eradication of the infection. Evidence confirm level: C. eradication Agreement: 100%. of infection? Are We recommend against serological tests to detect anti- Strength of serological H. pylori antibodies as a single test to confirm recommendation: tests eradication. Strong. Evidence needed to level: A. confirm Agreement: 100%. eradication of infection? External reviewers: Who was asked to review the clinical content of the CPG (External Review Panel? members):- - 19 -  Names Affiliations Dr. Mohamed El Guindy MD, Menofiya University Dr. Mostafa Hodhod MD, Ain Shams University Dr. Ahmed Megahed MD, Mansoura University Example of Dissemination and Implementation Proposed Resources Educational materials based on this Adapted CPG forH. pylori related diseases are made available in flow chart, including *Alarm signs include persistent right upper or right lower quadrant pain, dysphagia, odynophagia, persistent vomiting, gastrointestinal blood loss, involuntary weight loss, deceleration of linear growth, delayed puberty, unexplained fever, and a family history (Jones NL et al., 2017) **Refractoriness to oral iron is defined as failure to respond to treatment at a dose of at least 100 mg of elemental iron per day after 4 to 6 weeks of therapy (Hershko C and Camaschella C.2014) ***Chronic ITP is defined by ITP persistence beyond 12 months, with spontaneous recovery occurring in less than 10% of adults (William B and Mitchell MD, 2019) - 20 - ****Functional bowel disorders are heterogeneous group of disorder, the most prevalent of which is irritable bowel syndrome (IBS) and functional abdominal pain (FAP) syndrome. FAP characterized by frequent or continuous abdominal pain associated with a degree of loss of daily activity, in the absence in change in bowel habits (Farmer AD and Aziz Q.2014) - 21 -