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A Study to Evaluate the Effects of a Natural Supplement in Adults With Chronic Functional Constipation

NCT02073006 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2015-01-15

No results posted yet for this study

Summary

Constipation is common in the general population, especially in women and in the elderly. Hard stool is a complaint often associated with constipation, which suggests that stool softening would provide a major benefit in the strategy of treatment.

This investigative fibre product is primarily a soluble dietary fibre with added probiotics and a prebiotic. It is not digested in the small intestine and partly remains undigested by bacteria in the gut. Also, as probiotics are believed to help restore a healthy gut flora, reduce pH, assist with digestion of food and reduce gaseous by-products they may aid the improvement of intestinal motility.

The objective of this study is to assess if this investigative, fibre product effects the number of bowel movements per week and if this in turn impacts quality of life and symptoms of constipation.

Conditions

Interventions

DIETARY_SUPPLEMENT

Natural Fibre Supplement

Natural Fibre Supplement 2 doses per day for 4 weeks

Sponsors & Collaborators

  • Atlantia Food Clinical Trials

    lead INDUSTRY

Principal Investigators

  • Fergus Shanahan, MD,FRCP,FACG · Cork University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-07-31
Completion
2014-10-31

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02073006 on ClinicalTrials.gov