Effect of Prebiotics Versus Low FODMAPs Diet on Intestinal Microbiota and Symptoms
NCT ID: NCT02210572
Last Updated: 2015-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2014-08-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bimuno Galacto-oligosaccharide
Dietary intervention
Bimuno Galacto-oligosaccharide 1.37 g/d
Prebiotic versus low-FODMAPs diet
Low- FODMAPs diet
Dietary intervention
Low- FODMAPs diet
Interventions
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Bimuno Galacto-oligosaccharide 1.37 g/d
Prebiotic versus low-FODMAPs diet
Low- FODMAPs diet
Eligibility Criteria
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Inclusion Criteria
* Women and men between the ages of 18 and 80 years (bounds included at the inclusion visit).
* Normal body weight or with overweight (body mass index between 18.0 and 30.0 kg/m2 (bounds included)).
* Women of childbearing potential should be using or complying with one of the medically approved methods of contraception such as, but not exclusively, one of the following:
1. Birth control pill
2. Intra-uterine device (IUD)
3. Double barrier methods (such as condoms and spermicide)
4. Abstinence
* Willing to follow strict dietary instructions for the duration of the study
* Able to communicate well with the investigator and to comply with the requirements for the study.
Exclusion Criteria
* Disease/disorders which can interfere with the collection of the gas (hemorrhoids,..etc)
* Antecedents of digestive surgery, excluding appendicectomy
* Intake of antibiotics in the month (within 30 days) preceding the inclusion visit.
* Current use of any medications with potential central nervous system effects as judged by the investigator (including but not limited to antidepressants, anxiolytics, opiate pain medications)
* Taking drugs that might modify gastrointestinal function
* Change of dietary habits within the preceding 4 weeks (for instance start of a diet high in fiber) or planned change (For example to start a diet) during the period of the study
18 Years
80 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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Fernando Azpiroz, MD
Role: PRINCIPAL_INVESTIGATOR
Vall d'Hebron Research Institute
Locations
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Vall d'Hebron Research Institute
Barcelona, Barcelona, Spain
Countries
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References
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Huaman JW, Mego M, Manichanh C, Canellas N, Canueto D, Segurola H, Jansana M, Malagelada C, Accarino A, Vulevic J, Tzortzis G, Gibson G, Saperas E, Guarner F, Azpiroz F. Effects of Prebiotics vs a Diet Low in FODMAPs in Patients With Functional Gut Disorders. Gastroenterology. 2018 Oct;155(4):1004-1007. doi: 10.1053/j.gastro.2018.06.045. Epub 2018 Jun 30.
Other Identifiers
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PR(AG)296/2013/A-4/2014
Identifier Type: -
Identifier Source: org_study_id