NCT02194972

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2009

Typical duration for phase_3

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

May 1, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
Last Updated

August 24, 2018

Status Verified

July 1, 2014

Enrollment Period

3.4 years

First QC Date

July 17, 2014

Last Update Submit

August 22, 2018

Conditions

HypomotilityConstipation

Keywords

constipationcolon transit timegut microbiotasoluble dietary fiberdisturbance of gut microbiota in constipation

Outcome Measures

Primary Outcomes (1)

  • efficacy: intestinal transit time

    colonic transit time

    four weeks after inclusion

Secondary Outcomes (2)

  • efficacy: clinical symptoms

    four weeks after inclusion

  • efficacy: gut microbiota

    four weeks after inclusion

Study Arms (2)

soluble dietary fiber

EXPERIMENTAL

pectin, a kind of soluble dietary fiber

Drug: Pectin

Placebo

NO INTERVENTION

Placebo

Interventions

PectinDRUG

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

Also known as: soluble dietary fiber
soluble dietary fiber

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Mental disorders
  • Cancer
  • Inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Constipation

Interventions

Pectins

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

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

July 17, 2014

First Posted

July 21, 2014

Study Start

May 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

August 24, 2018

Record last verified: 2014-07