Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT04282551
Status:
UNKNOWN
Last Update Posted:
2021-10-12
First Post:
2019-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D009844', 'term': 'Oligosaccharides'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel study with three arms of 13 weeks in total per participant.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-11', 'studyFirstSubmitDate': '2019-12-06', 'studyFirstSubmitQcDate': '2020-02-21', 'lastUpdatePostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stool consistency', 'timeFrame': 'Stool consistency will be measured at different time points during a study period of 13 weeks.', 'description': 'Change in stool consistency measured by the a stool questionnaire; 5 points stool scale from 1 hard to 5 watery (modified Bristol Stool Form Scale)'}], 'secondaryOutcomes': [{'measure': 'Stool frequency in number of cases (%)', 'timeFrame': 'These outcome measures will be measured at different time point during a study period of 13 weeks.', 'description': 'Stool frequency - number of times a child has stools a day as reported in a diary.'}, {'measure': 'Stool consistency in number of cases (%)', 'timeFrame': 'These outcome measures will be measured at different time point during a study period of 13 weeks.', 'description': 'Stool consistency - % of stools in a certain stool scale score as measured via a 5 point stool scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oligosaccharides'], 'conditions': ['Functional Constipation']}, 'referencesModule': {'references': [{'pmid': '38576033', 'type': 'DERIVED', 'citation': 'Wegh CAM, Schoterman MHC, Vaughan EE, van der Zalm SCC, Smidt H, Belzer C, A Benninga M. Effect of prebiotic oligosaccharides on bowel habit and the gut microbiota in children with functional constipation (Inside study): study protocol for a randomised, placebo-controlled, multi-centre trial. Trials. 2024 Apr 5;25(1):238. doi: 10.1186/s13063-024-08050-8.'}]}, 'descriptionModule': {'briefSummary': 'In the present randomised double blind controlled study, the investigators will study the effects of oligosaccharides vs a placebo on the change in stool consistency and stool frequency in children with functional constipation.', 'detailedDescription': 'Functional constipation (FC) in children is a common gastrointestinal (GI) disorder with a worldwide prevalence ranging from 0.7% to 29.6%. Complaints include infrequent bowel movement, painful defecation due to hard and/or large stools, fecal incontinence, and abdominal pain. Although the condition is rarely life-threatening, it strongly impairs quality of life. Oligosaccharides have been shown to relieve constipation symptoms in young adults and elderly. However, sufficient evidence is lacking linking oligosaccharides intake to improve symptoms in children with FC. The investigators hypothesize that oligosaccharides might be able to relieve symptoms of constipation in young children as well, among which softening stools.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "In order to be eligible to participate in this study, a subject must meet all of the following criteria, as considered by a medical doctor:\n\n* Written informed consent\n* Aged 1-3 years\n* Children that meet the Rome IV criteria for functional constipation\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Children who suffer from any other GI complaints than functional constipation, known structural GI abnormalities, or previous GI surgery\n* Any condition that would make it unsafe for the child to participate.\n* Children with clinically significant cardiac, vascular, liver, pulmonary, psychiatric disorders, severe renal insufficiency, human immunodeficiency virus, acquired immunodeficiency syndrome, hepatitis B or C or known abnormalities of haematology, urinalysis, or blood biochemistry\n* Children who are allergic to cow's milk or fish\n* Use of antibiotics or other medicines or food supplements, and breast milk-feeding, 4 weeks prior to the study, except for the allowed escape medication\n* Children that participate in another clinical trial"}, 'identificationModule': {'nctId': 'NCT04282551', 'acronym': 'Inside', 'briefTitle': 'The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University and Research'}, 'officialTitle': 'The Effect of Oligosaccharides Versus a Placebo on Bowel Habits in Children With Functional Constipation', 'orgStudyIdInfo': {'id': 'NL70126.081.19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oligosaccharide group 1', 'interventionNames': ['Other: dietary intervention with oligosaccharides']}, {'type': 'EXPERIMENTAL', 'label': 'oligosaccharide group 2', 'interventionNames': ['Other: dietary intervention with oligosaccharides']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'interventionNames': ['Other: dietary intervention with oligosaccharides']}], 'interventions': [{'name': 'dietary intervention with oligosaccharides', 'type': 'OTHER', 'description': 'intervention with oligosaccharide 1 or 2, or placebo, given once a day', 'armGroupLabels': ['oligosaccharide group 1', 'oligosaccharide group 2', 'placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marc A. Benninga, Prof. MD', 'role': 'CONTACT', 'email': 'm.a.benninga@amsterdamumc.nl', 'phone': '003120-56680000'}], 'facility': "Emma Children's Hospital, UMC Amsterdam", 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Clara Belzer, PhD', 'role': 'CONTACT', 'email': 'clara.belzer@wur.nl', 'phone': '0031317-483742'}, {'name': 'Carrie A Wegh, MSc', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Clara Belzer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wageningen University and Research'}, {'name': 'Marc A Benninga, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Emma Children's Hospital, UMC Amsterdam"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University and Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, {'name': 'FrieslandCampina, Amersfoort, The Netherlands', 'class': 'UNKNOWN'}, {'name': 'Sensus (Royal Cosun), the Netherlands.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Clara Belzer', 'investigatorAffiliation': 'Wageningen University and Research'}}}}