Effects of Pectin Supplementation in Diarrhea-predominant... | NCT02270268

Studies
Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome

NCT02270268

Sponsor

Nanjing PLA General Hospital

Status

Completed

Last Update Posted

Mar 24, 2016Estimated

Enrollment

114Actual

Phase

Phase 3

Conditions

Irritable Bowel Syndrome

Interventions

Pectin
maltodextrin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Oct 10, 2014

First Submission Date that Met QC Criteria

Oct 17, 2014

First Posted Date

Oct 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2016

Last Update Posted Date

Mar 24, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Patients were randomized to receive either pectin or placebo. Treatment consisted of 6 weeks supplementation with pectin (fiber group) or placebo (maltodextrin). We evaluated the clinical symptoms, gut microbiota and the immune markers in two groups.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

114Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pectin	Experimental	a kind of soluble dietary fiber	Dietary Supplement: Pectin
Placebo	Placebo Comparator	maltodextrin	Dietary Supplement: maltodextrin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pectin	Dietary Supplement	Pectin （Andeli Ltd. Yantai, China）, 24g/d for six weeks	pectin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
efficacy: gut microbiota	real-time PCR	six weeks after inclusion
efficacy: cytokine ratios	Cytokine production	six weeks after inclusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Mental disorders
Cancer
Inflammatory bowel disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tao Gao, M.D.	Nanjing PLA General Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010368	Pectins
C008315	maltodextrin

Ancestor Terms

ID	Term
D001704	Biopolymers
D011108	Polymers
D046911	Macromolecular Substances
D011134	Polysaccharides

Browse Leaves

Not provided

Browse Branches

Not provided