Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT04791956
Status:
UNKNOWN
Last Update Posted:
2023-04-12
First Post:
2021-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prebiotic EffecT InfanTs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D056692', 'term': 'Prebiotics'}], 'ancestors': [{'id': 'D004043', 'term': 'Dietary Fiber'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011135', 'term': 'Polysaccharides, Bacterial'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2021-03-05', 'studyFirstSubmitQcDate': '2021-03-09', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stool consistency', 'timeFrame': '4 weeks', 'description': 'Assessed by the parents in a continuous daily bowel diary over the study period'}], 'secondaryOutcomes': [{'measure': 'Stool frequency', 'timeFrame': '4 weeks', 'description': 'Assessed by daily parental reporting'}, {'measure': 'Stool colour', 'timeFrame': '4 weeks', 'description': 'Assessed by the parents in a continuous daily bowel diary over the study period'}, {'measure': 'Stool amount', 'timeFrame': '4 weeks', 'description': 'Assessed by the parents in a continuous daily bowel diary over the study period'}, {'measure': 'Sleep', 'timeFrame': '4 weeks', 'description': 'Change in sleep behavior assessed by parental questionnaire (Brief Infant Sleep Questionnaire) at the beginning and end of the trial'}, {'measure': 'Stool pH', 'timeFrame': '4 weeks', 'description': 'change in stool pH over a four week period'}, {'measure': 'stool short-chain fatty acids', 'timeFrame': '4 weeks', 'description': 'change in amount and relative distribution of short-chain fatty acids in stool over a four week period'}, {'measure': 'Tolerance and acceptability', 'timeFrame': '4 weeks', 'description': 'Tolerance and acceptability of the study products assessed by customized parental questionnaire at the end of the trial'}, {'measure': 'Body weight', 'timeFrame': '4 weeks', 'description': 'changes in body weight (kg) assessed by an investigator'}, {'measure': 'Body height', 'timeFrame': '4 weeks', 'description': 'changes in body height (m) assessed by an investigator'}, {'measure': 'Faecal Microbiota', 'timeFrame': '4 weeks', 'description': 'Stool samples will be analysed by appropriate molecular biological methods like 16S rRNA gene sequencing to gain insight into the composition of the gut microbiota.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiota, gastrointestinal health'], 'conditions': ['Infant Development', 'Healthy', 'Diet, Healthy']}, 'referencesModule': {'references': [{'pmid': '27931142', 'type': 'BACKGROUND', 'citation': 'Closa-Monasterolo R, Ferre N, Castillejo-DeVillasante G, Luque V, Gispert-Llaurado M, Zaragoza-Jordana M, Theis S, Escribano J. The use of inulin-type fructans improves stool consistency in constipated children. A randomised clinical trial: pilot study. Int J Food Sci Nutr. 2017 Aug;68(5):587-594. doi: 10.1080/09637486.2016.1263605. Epub 2016 Dec 8.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on stool consistency in infants.', 'detailedDescription': 'The fermentation of prebiotic inulin-type fructans leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA). The introduction of solid foods is frequently associated with harder stools which are more difficult to pass and can cause painful defecations. Subsequently, the changes in bowel habits associated with weaning and the introduction of complementary foods could be minimized by the addition of prebiotics to complementary foods and, thus, the transition from milk-feeding to family food could be facilitated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Child is healthy at the time of pre-examination\n* Child was born on term or preterm (≥ 32 weeks of gestation)\n* Child is aged 6-12 months at the time of pre-examination (for preterm born children (32-37 weeks of gestation), corrected age will be applied)\n* Normal growth (weight and length for age between 10th and 90th percentiles, Fenton and Kim 2013)\n* Child receives at least one meal per day as complementary feeding\n* Child and legal guardian are able and willing to follow the study instructions\n* Child is suitable for participation in the study according to the investigator/physician/study personnel\n* Written informed consent is given by parent or legal guardian\n\nExclusion Criteria:\n\n* No legal guardian's command of any local language\n* Organic causes of defecation disorders incl. Hirschsprung disease, Spina bifida, hypothyroidism etc.\n* Other metabolic or renal abnormalities or psychomotor retardation (e.g. hypotonia)\n* Child has allergy to cow's milk protein or lactose intolerance\n* Child has been or is currently breast-fed more than once daily (6 weeks before intervention)\n* Child has mostly loose or watery stools in ≥ 50% of defecations\n* Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)\n* Use of laxatives or pre- or probiotic supplements in the previous 4 weeks before intervention\n* Child is currently involved or will be involved in another clinical or food study"}, 'identificationModule': {'nctId': 'NCT04791956', 'acronym': 'PETIT', 'briefTitle': 'Prebiotic EffecT InfanTs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beneo-Institute'}, 'officialTitle': 'Double-blind, Randomized Placebo-controlled Trial Investigating the Effect of Prebiotic Inulin-type Fructans on Bowel Habits of Infants', 'orgStudyIdInfo': {'id': '20018m-jhr'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prebiotic', 'description': 'Inulin-type fructans', 'interventionNames': ['Dietary Supplement: Prebiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Maltodextrin', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Prebiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily intake of Inulin-type fructans from chicory', 'armGroupLabels': ['Prebiotic']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily intake of maltodextrin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43204', 'city': 'Reus', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Carme Rubio', 'role': 'CONTACT'}], 'facility': 'Hospital Universitari Sant Joan de Reus - Magatzem', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}, {'zip': '43005', 'city': 'Tarragona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Mariona Gispert', 'role': 'CONTACT'}], 'facility': 'Hospital Universitari Joan XXIII de Tarragona - Almacén general', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}], 'centralContacts': [{'name': 'Stephan Theis, PhD', 'role': 'CONTACT', 'email': 'stephan.theis@beneo.com', 'phone': '+49 6359 803 287'}], 'overallOfficials': [{'name': 'Ricardo Closa Monasterolo, Phd, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Paediatrics Unit, University Hospital Joan XXIII, Tarragona, Spain. Paediatrics Research Unit on Nutrition and Human Development, Universitat Rovira i Virgili, Reus, Spain'}, {'name': 'Joaquin Escribano Subias, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Paediatrics Unit, University Hospital Sant Joan, Reus, Spain. Paediatrics Research Unit on Nutrition and Human Development, Universitat Rovira i Virgili, Reus, Spain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beneo-Institute', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hospital Universitari Sant Joan de Reus', 'class': 'OTHER'}, {'name': 'Hospital de Tarragona Joan XXIII', 'class': 'UNKNOWN'}, {'name': 'Institut Investigacio Sanitaria Pere Virgili', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}