NCT02270268

Brief Summary

The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary fiber, on clinical symptoms, gut microbiota and the immune status in patients with diarrhea-predominant irritable bowel syndrome

Trial Health

100
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2011

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, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 10, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

1.9 years

First QC Date

October 10, 2014

Last Update Submit

March 23, 2016

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndromeGut microbiotaSoluble dietary fiber

Outcome Measures

Primary Outcomes (1)

  • efficacy: change of stool frequency, faecal form and clinical symptoms score

    change from baseline in stool frequency, faecal form (Bristol stool scale) and clinical symptoms score (7-point Likert scale) at six weeks

    six weeks after inclusion

Secondary Outcomes (2)

  • efficacy: gut microbiota

    six weeks after inclusion

  • efficacy: cytokine ratios

    six weeks after inclusion

Study Arms (2)

pectin

EXPERIMENTAL

a kind of soluble dietary fiber

Dietary Supplement: Pectin

Placebo

PLACEBO COMPARATOR

maltodextrin

Dietary Supplement: maltodextrin

Interventions

PectinDIETARY_SUPPLEMENT

Pectin （Andeli Ltd. Yantai, China）, 24g/d for six weeks

pectin
maltodextrinDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients(age≧18y)
  • Admitted for diarrhea-predominant irritable bowel syndrome

You may not qualify if:

  • Mental disorders
  • Cancer
  • Inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Pectinsmaltodextrin

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

BiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Tao Gao, M.D.

    Nanjing PLA General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nanjing PLA General Hospital

Study Record Dates

First Submitted

October 10, 2014

First Posted

October 21, 2014

Study Start

November 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

March 24, 2016

Record last verified: 2016-03