Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06959758
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Probiotics (BioKid LR - Contains Nine Different Species of Probiotics Bacteria Including L. Reuteri) in Children With Functional Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2025-05-05', 'studyFirstSubmitQcDate': '2025-05-05', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Constipation Recurrence', 'timeFrame': '52 weeks', 'description': 'Time to recurrence of constipation after PEG withdrawal necessitating retreatment with PEG.\n\nThis measures how long it takes for constipation to return after stopping laxative treatment, requiring the child to start PEG again.'}], 'secondaryOutcomes': [{'measure': 'Intractable Constipation', 'timeFrame': '12 weeks', 'description': 'Prevalence of intractable constipation after the initial 12 weeks of PEG treatment'}, {'measure': 'Normal Bowel Movements without PEG', 'timeFrame': '52 weeks', 'description': 'Failure to maintain normal bowel movements (defined as \\> 3 spontaneous bowel movement per week) with no fecal incontinence (among children older than 4 year old) without necessitating PEG re-treatment, at weeks 24 and 52.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['constipation', 'laxatives', 'PEG 350'], 'conditions': ['Constipation']}, 'referencesModule': {'references': [{'pmid': '26382580', 'type': 'BACKGROUND', 'citation': 'Eskesen D, Jespersen L, Michelsen B, Whorwell PJ, Muller-Lissner S, Morberg CM. Effect of the probiotic strain Bifidobacterium animalis subsp. lactis, BB-12(R), on defecation frequency in healthy subjects with low defecation frequency and abdominal discomfort: a randomised, double-blind, placebo-controlled, parallel-group trial. Br J Nutr. 2015 Nov 28;114(10):1638-46. doi: 10.1017/S0007114515003347. Epub 2015 Sep 18.'}, {'pmid': '15756221', 'type': 'BACKGROUND', 'citation': 'Banaszkiewicz A, Szajewska H. Ineffectiveness of Lactobacillus GG as an adjunct to lactulose for the treatment of constipation in children: a double-blind, placebo-controlled randomized trial. J Pediatr. 2005 Mar;146(3):364-9. doi: 10.1016/j.jpeds.2004.10.022.'}, {'pmid': '26348685', 'type': 'BACKGROUND', 'citation': 'Modin L, Walsted AM, Rittig CS, Hansen AV, Jakobsen MS. Follow-up in Childhood Functional Constipation: A Randomized, Controlled Clinical Trial. J Pediatr Gastroenterol Nutr. 2016 Apr;62(4):594-9. doi: 10.1097/MPG.0000000000000974.'}, {'pmid': '20530072', 'type': 'BACKGROUND', 'citation': 'Bongers ME, van Wijk MP, Reitsma JB, Benninga MA. Long-term prognosis for childhood constipation: clinical outcomes in adulthood. Pediatrics. 2010 Jul;126(1):e156-62. doi: 10.1542/peds.2009-1009. Epub 2010 Jun 7.'}, {'pmid': '24345831', 'type': 'BACKGROUND', 'citation': 'Tabbers MM, DiLorenzo C, Berger MY, Faure C, Langendam MW, Nurko S, Staiano A, Vandenplas Y, Benninga MA; European Society for Pediatric Gastroenterology, Hepatology, and Nutrition; North American Society for Pediatric Gastroenterology. Evaluation and treatment of functional constipation in infants and children: evidence-based recommendations from ESPGHAN and NASPGHAN. J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):258-74. doi: 10.1097/MPG.0000000000000266.'}, {'pmid': '21382575', 'type': 'BACKGROUND', 'citation': 'Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate whether a probiotic supplement, BioKid LR®, can help maintain normal bowel movements after stopping laxative treatment (PEG 3350) in children aged 6 months to 17 years with functional constipation.\n\nThe main questions it aims to answer are:\n\nDoes taking BioKid LR reduce the chance of constipation coming back after stopping PEG? Can BioKid LR help children maintain regular bowel movements without needing to restart laxatives? Researchers will compare children who take BioKid LR with those who take a placebo (an inactive powder) to see if the probiotic helps prevent constipation from returning.\n\nParticipants will:\n\nTake PEG 3350 (a common laxative) for 12 weeks along with either BioKid LR or a placebo.\n\nAfter 12 weeks, begin gradually stopping PEG while continuing with BioKid LR or placebo for another 12 weeks.\n\nThen continue only with BioKid LR or placebo for an additional 28 weeks (total study duration: 52 weeks).\n\nKeep a stool diary to track bowel habits and any side effects. Attend 5 study visits for physical exams and monitoring (weeks 0, 12, 24, 38, 52).\n\nThe study includes 80 children and is double-blinded, meaning neither the doctors nor the participants know who is receiving the real probiotic or the placebo.\n\nThe primary outcome is how long it takes for constipation to return after stopping PEG, requiring retreatment.\n\nSecondary outcomes include:\n\nHow many children still need long-term treatment. How many have regular bowel movements without accidents (in children over 4 years old).\n\nStool consistency and frequency. Children with certain medical conditions (like celiac disease or hypothyroidism) or who are taking medications that cause constipation cannot participate.\n\nThis study is supported by Supherb Group, Israel, but they are not involved in designing or analyzing the research. The study has been approved by an ethics committee and follows international ethical guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 0.5 - 17 years\n2. Diagnosis of FC based on Rome IV criteria\n\nExclusion Criteria:\n\n1. Children with chronic diseases which could cause constipation: Celiac disease, food allergy, Hypothyroidism, Inflammatory Bowel Disease, electrolytes disturbances, Cystic fibrosis, Hirschsprung disease, Neuropathic conditions (Spinal cord trauma, Neurofibromatosis, Tethered cord) or intestinal pseudo-obstruction\n2. Prematurity (\\<34 weeks)\n3. S/P intestinal surgery\n4. Immunodeficiency\n5. Malignancy\n6. Children treated with medications associated with constipation. \\*'}, 'identificationModule': {'nctId': 'NCT06959758', 'briefTitle': 'Effects of Probiotics (BioKid LR - Contains Nine Different Species of Probiotics Bacteria Including L. Reuteri) in Children With Functional Constipation', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Effects of Probiotics (BioKid LR - Contains Nine Different Species of Probiotics Bacteria Including L. Reuteri) in Children With Functional Constipation: a Double Blind Randomized Control Trial', 'orgStudyIdInfo': {'id': '0151-23-EMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BioKid Arm', 'description': 'This arm includes children receiving the BioKid LR probiotic supplement alongside standard laxative treatment (PEG 3350), followed by BioKid LR alone after PEG tapering.', 'interventionNames': ['Dietary Supplement: Probiotic Arm']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'This arm includes children receiving a placebo (maltodextrin powder) alongside standard laxative treatment (PEG 3350), followed by placebo alone after PEG tapering.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Probiotic Arm', 'type': 'DIETARY_SUPPLEMENT', 'description': 'It is administered daily to children with functional constipation, alongside standard laxative treatment (PEG 3350) for the first 12 weeks, and then continued alone for the remainder of the 52-week study period. The study evaluates whether BioKid LR® helps maintain normal bowel movements after stopping PEG.', 'armGroupLabels': ['BioKid Arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'A placebo maltodextrin powder is administered daily to children with functional constipation, alongside standard laxative treatment (PEG 3350) for the first 12 weeks, and then continued alone for the remainder of the 52-week study period.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Afula', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Inbal Rish, PhD', 'role': 'CONTACT', 'email': 'inbal_la@clalit.org.il', 'phone': '00972528877977'}], 'facility': 'Emek Medical Center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'centralContacts': [{'name': 'Ferass Abu Hanna, MD', 'role': 'CONTACT', 'email': 'ferass@Gmail.com', 'phone': '00972546336583'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferass Abu Hanna', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ambrosia - SupHerb Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ferass Abu Hanna', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}