Clinical Effects of Soluble Dietary Fiber Supplementation

NCT ID: NCT02194972

Last Updated: 2018-08-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-10-31

Brief Summary

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The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary fiber, on colonic transit time, clinical symptoms and the gut microbiota in adults with slow-transit constipation.

Detailed Description

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Patients were randomized to receive either pectin or placebo. Treatment consisted of 4 weeks supplementation with pectin (fiber group) or placebo. We evaluated the colonic transit time, constipation symptoms and fecal bacterial population in two groups.

Conditions

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Hypomotility Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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soluble dietary fiber

pectin, a kind of soluble dietary fiber

Group Type EXPERIMENTAL

Pectin

Intervention Type DRUG

pectin (Andeli Ltd. Yantai, China), 24g/d for 4weeks

Placebo

Placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pectin

pectin (Andeli Ltd. Yantai, China), 24g/d for 4weeks

Intervention Type DRUG

Other Intervention Names

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soluble dietary fiber

Eligibility Criteria

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Inclusion Criteria

* All patients(age≧18y)
* Admitted for slow-transit constipation were considered eligible

Exclusion Criteria

* Mental disorders
* Cancer
* Inflammatory bowel disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gao Tao

Nanjing PLA General Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tao Gao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Nanjing PLA General Hospital

Other Identifiers

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2011NLY42

Identifier Type: -

Identifier Source: org_study_id

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