Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT01848535
Status:
COMPLETED
Last Update Posted:
2013-11-20
First Post:
2013-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of GOS Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C072242', 'term': "4'-galactooligosaccharide"}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-19', 'studyFirstSubmitDate': '2013-04-16', 'studyFirstSubmitQcDate': '2013-05-02', 'lastUpdatePostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gastrointestinal complains', 'timeFrame': 'during the study (26 day) via a diary'}], 'primaryOutcomes': [{'measure': 'Microbiota composition', 'timeFrame': 'evaluation between july and september 2013', 'description': 'Microbiota composition of the collected faecal sample will be investigated using a phylogenetic microarray, the Intestinal-Chip. With this microarray, more than 400 species of the intestinal microbiota can be detected.\n\nBifidobacteria and Lactobacillus as beneficial bacteria as well as Enterobacteriaceae and possible other pathogens (Cells/ g faecal dry weight) will also be measured using a real-time PCR with specific primers.'}], 'secondaryOutcomes': [{'measure': 'Microbiota activity', 'timeFrame': 'evaluation between july and september 2013', 'description': 'The Short Chain Fatty acid (SCFA) amount produced will be measured using chromatographic approaches (Gas Chromatography, High Performance Liquid Chromatography).\n\nThe remaining GOS will be measured with High Performance Anion Exchange Chromatography (HPAEC) or with Capillary Electrophoresis -Light Induced Fluorescence, which has a better resolution than HPAEC.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intestinal microbiota composition', 'intestinal microbiota activity', 'gastro-intestinal complains'], 'conditions': ['Colonic Diseases [C06.405.469.158]']}, 'referencesModule': {'references': [{'pmid': '19442165', 'type': 'BACKGROUND', 'citation': 'Saulnier DM, Kolida S, Gibson GR. Microbiology of the human intestinal tract and approaches for its dietary modulation. Curr Pharm Des. 2009;15(13):1403-14. doi: 10.2174/138161209788168128.'}]}, 'descriptionModule': {'briefSummary': 'Prebiotics are thought to be a potential means to prevent antibiotic-associated diarrhoea because of their ability to stimulate beneficial bacteria. In-vitro results showed a promising recovery of Bifidobacteria combined with an increase of Short Chain Fatty Acids (SCFA) upon Galacto-oligosaccharides (GOS) supplementation to amoxicillin-treated microbiota. As the microbiota is nowadays considered as a key factor in human health, a further understanding of the gut microbiota functioning in-vivo is essential. This understanding of the use of specific prebiotics may possibly be beneficial in the prevention or recovery of antibiotic-disturbed microbiota. As the effects of GOS supplementation on the microbiota composition and activity from healthy adults receiving amoxicillin have never been tested in-vivo, the investigators propose the current study as a proof of principle.\n\nObjective:\n\nTo explore whether the promising effects of GOS supplementation on the composition and activity of gut microbiota from healthy adults as found by in-vitro, can also be observed in-vivo.\n\nStudy population:\n\n10 healthy men and women volunteers, 18 - 40 yr old'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-40 \\*\n* BMI: 18.5-25 kg/m2\n* Stable weight over the last 6 months\n* Western diet\n* Availability of information about birth by caesarean section and breast-feeding\n* Regular defecation (\\~1day)\n* Healthy as judge by the participant himself\n* Having signed the informed consent form\n\nExclusion Criteria:\n\n* Smoking or drug use\n* Pregnant (include planning to be or gave birth in the last 6 months) or lactating woman\n* Using contraceptive pill\n* Gastro-intestinal diseases (e.g. irritable bowel syndrome, inflammatory bowel disease)\n* Traveling to an Asian, African or south American country \\< 6 months before the study\n* Hypersensitivity or food allergy for products used in this study (e.g. Lactose, Penicillin)\n* Having hepatic disease and renal failure\n* Using medication other than paracetamol, acetylsalicylic acid (aspirin), hay fever, asthma\n* Not willing to have the family doctor be informed about participation to the study.\n* Antibiotic use \\< 3 months before the study\n* More than 3 antibiotic treatments in the last 2 years.\n* Probiotic or prebiotic use \\< 1 month before the study\\*'}, 'identificationModule': {'nctId': 'NCT01848535', 'acronym': 'GOS', 'briefTitle': 'Effect of GOS Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'Effect of Galacto-Oligosaccharides Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults : a Proof of Principal Study', 'orgStudyIdInfo': {'id': 'ABRnr42438'}, 'secondaryIdInfos': [{'id': 'WUR42438', 'type': 'OTHER', 'domain': 'wageningen university'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'GOS addition', 'description': 'All subjects will receive amoxicillin (375 mg 3x per day) for 5 days. Group 1 receives a drink with GOS (2,5 g 3x per day) simultaneously to the antibiotic for 5 days and after the antibiotic treatment for another 7 days. The intervention products should be consumed at breakfast/lunch/dinner.', 'interventionNames': ['Dietary Supplement: GOS addition', 'Dietary Supplement: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo (maltodextrine)', 'description': 'All subjects will receive amoxicillin (375 mg 3x per day) for 5 days. Group 2 receives a drink with placebo, maltodextrin(2,5 g 3x per day) simultaneously to the antibiotic for 5 days and after the antibiotic treatment for another 7 days. The intervention products should be consumed at breakfast/lunch/dinner.', 'interventionNames': ['Dietary Supplement: GOS addition', 'Dietary Supplement: Placebo']}], 'interventions': [{'name': 'GOS addition', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Galacto-oligosaccharide', 'Vivinal GOS'], 'description': 'GOS (2.5g 3x per day) supplemented during 12 days', 'armGroupLabels': ['GOS addition', 'placebo (maltodextrine)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['maltodextrine'], 'description': 'Maltodextrine(2.5g 3x per day) supplemented during 12 days', 'armGroupLabels': ['GOS addition', 'placebo (maltodextrine)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6703HD', 'city': 'Wageningen', 'country': 'Netherlands', 'facility': 'Laboratory of Food Chemistry', 'geoPoint': {'lat': 51.97, 'lon': 5.66667}}], 'overallOfficials': [{'name': 'Stephanie Ladirat, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wageningen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}