Clinical Effects of Soluble Dietary Fiber Supplementation

Phase 3CompletedNCT02194972

Nanjing PLA General Hospital80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypomotility Constipation

Interventions

PectinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients(age≧18y) * Admitted for slow-transit constipation were considered eligible Exclusion Criteria: * Mental disorders * Cancer * Inflammatory bowel disease

Outcomes

Primary Outcomes

efficacy: intestinal transit time

colonic transit time

Time frame: four weeks after inclusion

Secondary Outcomes

efficacy: clinical symptoms

Wexner constipation score

Time frame: four weeks after inclusion

efficacy: gut microbiota

real-time PCR

Time frame: four weeks after inclusion

Data from ClinicalTrials.gov

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