NCT01847950

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

1.1 years

First QC Date

December 6, 2012

Last Update Submit

October 4, 2018

Conditions

Functional Constipation

Outcome Measures

Primary Outcomes (1)

  • Frequency of stool emission

    6 weeks

Secondary Outcomes (1)

  • Stool consistency (Bristol scale)

    6 weeks

Other Outcomes (1)

  • Transit time

    6 weeks

Study Arms (2)

short-chain fructo-oligosaccharides

EXPERIMENTAL

Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks

Dietary Supplement: Short-chain fructo-oligosaccharides

Maltodextrin

PLACEBO COMPARATOR

maltodextrins are consummed at 5g/day for 6 weeks

Dietary Supplement: Maltodextrin

Interventions

Short-chain fructo-oligosaccharidesDIETARY_SUPPLEMENT

Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks

short-chain fructo-oligosaccharides
MaltodextrinDIETARY_SUPPLEMENT
Maltodextrin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects with functional constipation

You may not qualify if:

  • subjects treated with laxative treatments
  • subjects consuming more than 25g/day of dietary fibres
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRNH-CRV Avicenne Hospital

Bobigny, 93009, France

Location

MeSH Terms

Interventions

maltodextrin

Study Officials

  • Robert Benamouzig, Pr

    CRNH - CRV Avicenne Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2012

First Posted

May 7, 2013

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Study Completion

April 1, 2014

Last Updated

October 5, 2018

Record last verified: 2018-10

Locations

FR(1)