Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT06310733
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Probiotics, Lactobacillus GG, in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-03-06', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs', 'timeFrame': '12 weeks', 'description': 'Faces pain scale (0-6); higher scores mean a worse outcome.'}, {'measure': 'The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs', 'timeFrame': '12 weeks', 'description': 'Visual analog scale (0-10); higher scores mean a worse outcome.'}, {'measure': 'The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs', 'timeFrame': '12 weeks', 'description': 'Daily food and symptom record'}], 'secondaryOutcomes': [{'measure': 'To measure daily pain score in children with and without FAPDs', 'timeFrame': '12 weeks', 'description': 'Faces pain scale (0-6); higher scores mean a worse outcome.'}, {'measure': 'To measure daily pain score in children with and without FAPDs', 'timeFrame': '12 weeks', 'description': 'Visual analog scale (0-10); higher scores mean a worse outcome.'}, {'measure': 'To measure daily pain score in children with and without FAPDs', 'timeFrame': '12 weeks', 'description': 'Daily food and symptom record'}, {'measure': 'To compare the diversity of fecal microbiota in children with FAPDs who took probiotics and those who did not', 'timeFrame': '4 weeks', 'description': 'stool samples for rDNA sequencing before and after 4 weeks of treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional Abdominal Pain Syndrome', 'Brain-Gut-Microbiome Axis', 'microbiome', 'irritable bowel syndrome', 'microbiota'], 'conditions': ['Functional Abdominal Pain Syndrome']}, 'descriptionModule': {'briefSummary': "Recurrent or chronic abdominal pain is one of the common gastrointestinal problems in children. While most children do not have organic origins (so called functional abdominal pain disorders; FAPDs), the symptoms can nevertheless be severe enough to impair the patient's quality of life, growth, and development. To help rule out organic disorders and diagnose this condition, some individuals underwent multiple invasive and costly studies.\n\nGenerally, the diagnosis of FAPDs is based on clinical symptoms and criteria, it can be divided into irritable bowel syndrome (IBS), abdominal migraine, functional abdominal pain (FAP) and functional dyspepsia (FD). Approximately 14% of children globally, between the ages of 4 and 18, experience functional abdominal pain issues8. In Thailand, the prevalence of FAPDs among adolescents (mean age of 16 years) was 5.3%, functional dyspepsia and irritable bowel syndrome were found to be the most prevalent subtypes.\n\nThe pathogenesis of FAPDs is believed to result from disruptions in the microbiota-gut-brain axis, which may happen early in life or throughout. Hence, several studies, specifically in western countries, reported the role of probiotics, specifically Lactobacillus rhamnosus GG (LGG), in modulating abdominal symptoms in children with FAPDs.\n\nIt is widely known that the diversity of gut microbiota depends on multiple factors including ethnicity, mode of delivery, dietary and environmental factors. However, the studies on the use of probiotics in pediatric patients with FAPDs have been mainly conducted in western countries. Since there are limited studies on the effectiveness of probiotics in Asian children with FAPDs, the investigators aim to evaluate the effects of probiotics, LGG, in the treatment of children who suffered from FAPDs.\n\nThe secondary objectives are to measure daily pain score in children with and without FAPDs, to evaluate and compare the diversity of fecal microbiota in children with FAPDs and those without FAPDs, and to compare the diversity of fecal microbiota between children with FAPDs who took probiotics and those who did not."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children, aged 6-15 years old, with a diagnosis of IBS or FAP, according to the Rome IV diagnostic criteria. The diagnosis of IBS or FAP was based on a clinical interview performed by pediatric gastroenterologist.\n\nFor healthy controls: non-obese children, aged 6-15 years old, without any gastrointestinal symptoms at the time of recruitment.\n\nExclusion Criteria:\n\n* Children who\n\n 1. had any chronic diseases, including neurobehavioral disorders\n 2. received treatment with antibiotics/probiotics in the previous 2 months\n 3. received medication that affects gastrointestinal motility in the previous 1 week\n 4. had a pain history suggestive of functional dyspepsia/aerophagia/abdominal migraine/functional constipation\n 5. exhibited growth failure\n 6. had gastrointestinal obstructions/stricture\n 7. displayed alarming signs of organic condition\n 8. had previous abdominal surgery\n 9. had abnormal baseline test results as part of their standard work-up (e.g. complete blood counts; erythrocyte sedimentation rate; liver-pancreas-kidney function tests; stool examination for occult blood, ova, and parasites; fecal calprotectin; urinalysis; abdominal ultrasound; 13C-urea breath test; gastric emptying study, if any)\n 10. had family history of peptic ulcer disease or inflammatory bowel disease'}, 'identificationModule': {'nctId': 'NCT06310733', 'briefTitle': 'The Effects of Probiotics, Lactobacillus GG, in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Songkla University'}, 'officialTitle': 'The Effects of Probiotics, Lactobacillus GG, in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'REC 66-517-1-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LGG (ATCC 53103)', 'description': 'A suspension of freeze-dried LGG ATCC53103 in excipients in an aqueous solution supplied in a 10-mL dark bottle with a delivery cap.', 'interventionNames': ['Drug: LGG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'An identical aqueous solution in appearance and taste but without LGG.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LGG', 'type': 'DRUG', 'description': 'Participants will take 10 mL of a suspension of freeze-dried LGG ATCC53103 in excipients in an aqueous solution, supplied in a 10-mL dark bottle with a delivery cap.', 'armGroupLabels': ['LGG (ATCC 53103)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will take 10 mL of an identical aqueous solution in appearance and taste but without LGG, supplied in a 10-mL dark bottle.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Songkhla', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Atchariya Chanpong, M.D, Ph.D.', 'role': 'CONTACT', 'email': 'atchariya.c@psu.ac.th', 'phone': '+6674451250'}], 'facility': 'Atchariya Chanpong', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}], 'centralContacts': [{'name': 'Atchariya Chanpong, M.D, Ph.D.', 'role': 'CONTACT', 'email': 'atchariya.c@psu.ac.th', 'phone': '6674451250'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Songkla University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division of Gastroenterology and Hepatology, Department of Pediatrics, Faculty of Medicine', 'investigatorFullName': 'Atchariya Chanpong', 'investigatorAffiliation': 'Prince of Songkla University'}}}}