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NCT01847950 Clinical Trial

Effects of scFOS on Stool Frequency in People With Functionnal Constipation

Functional Constipation Clinical Trial

Official title:
Randomized, Placebo-controlled Double-blind Study to Evaluate the Effects of Fructo-oligosachharides on Increase of Stool Frequency in Constipated People

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01847950
Other study ID # ConstiFOS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2012
Est. completion date April 2014

Study information
Verified date October 2018
Source Syral
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and constistency of stools in subjects with functional constipation

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date April 2014
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- subjects with functional constipation

Exclusion Criteria:

- subjects treated with laxative treatments

- subjects consuming more than 25g/day of dietary fibres

- pregnant women

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Short-chain fructo-oligosaccharides
Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks
• Maltodextrin

Locations
Country Name City State
France CRNH-CRV Avicenne Hospital Bobigny

Sponsors (1)
Lead Sponsor Collaborator
Syral

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Other Transit time 6 weeks
Primary Frequency of stool emission 6 weeks
Secondary Stool consistency (Bristol scale) 6 weeks
See also
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Not yet recruiting NCT01913665 - The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation N/A
Completed NCT01348152 - Effect of TU-100 in Patients With Functional Constipation Phase 2
Completed NCT01622972 - Mode of Action of Moviprep Phase 4
Completed NCT01212146 - Probiotic-enriched Artichoke in Functional Constipation N/A
Completed NCT04231162 - Effect of an 8-week Bifidobacterium Lactis HN019 Supplementation on Functional Constipation N/A
Not yet recruiting NCT03639142 - Dried Plums (Prunes) vs. Polyethylene Glycol 4000 for Treatment of Functional Constipation in Children Phase 3
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Completed NCT02592200 - Effect of Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women N/A
Completed NCT03707002 - Effect of scFOS on Increase in Stool Frequency in Constipated People N/A
Recruiting NCT06083311 - The Efficacy of a Probiotic for Functional Constipation (FC) N/A
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Recruiting NCT06196073 - Visceral Osteopathy in Functional Constipation N/A
Active, not recruiting NCT04026113 - Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC) Phase 3
Completed NCT02359396 - A Randomized, Open-label, Three-arm Study of MZRW on Tolerability, Exposure and Pharmacokinetics Phase 1
Recruiting NCT01274793 - Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy Phase 1
Enrolling by invitation NCT04166058 - Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C Phase 3