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CompletedNCT02194972Updated Aug 24, 2018

Clinical Effects of Soluble Dietary Fiber Supplementation

A Phase 3 interventional study of Pectin in Hypomotility and Constipation, sponsored by Nanjing PLA General Hospital. Completed. Open to participants aged 18 Years to 78 Years. Per ClinicalTrials.gov, last updated 2018-08-24.

Sponsored by Nanjing PLA General Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 78 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Hypomotility
  • Constipation

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Keywords

  • constipation
  • colon transit time
  • gut microbiota
  • soluble dietary fiber
  • disturbance of gut microbiota in constipation
03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 80 is close to the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Nanjing PLA General Hospital is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 78 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Mental disorders
  • Cancer
  • Inflammatory bowel disease
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    soluble dietary fiber

    pectin, a kind of soluble dietary fiber

    Drug: Pectin

  • No intervention
    Placebo

    Placebo

Interventions

  • DrugPectin

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

    Also known as: soluble dietary fiber

06

What researchers measure

Primary outcomes

  1. efficacy: intestinal transit time

    colonic transit time

    Time frame: four weeks after inclusion

Secondary outcomes

  1. efficacy: clinical symptoms

    Wexner constipation score

    Time frame: four weeks after inclusion

  2. efficacy: gut microbiota

    real-time PCR

    Time frame: four weeks after inclusion

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02194972
Lead sponsor
Nanjing PLA General Hospital
Responsible party
Gao Tao (Nanjing PLA General Hospital, Nanjing PLA General Hospital) — Principal investigator
First posted
Jul 21, 2014
Start date
May 2009
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Aug 24, 2018

Study contacts

Tao Gao, M.D.
principal investigator · Nanjing PLA General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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