Status:

COMPLETED

The Effects of Enzyme-rich Malt Extract on Chronic Constipation

Lead Sponsor:

The Functional Gut Clinic

Conditions:

Constipation

Quality of Life

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

Participants with constipation will take enzyme-rich malt extract for 4 weeks whilst completing a daily bowel habit diary before and during intervention.

Detailed Description

This pilot study is an open label, pre-post interventional study to evaluate the use of ERME in the treatment of people with chronic constipation. This study involves eligible participants that have ...

Eligibility Criteria

Inclusion

  • Participant has diagnosis of chronic constipation according to the KESS score.
  • Participant can communicate and understand English.
  • Participant has a body mass index (BMI) between 18.5 and 34.9kg/m2 (bounds included).

Exclusion

  • Dependant use of opioid-based medications.
  • New use of prokinetic therapy during the study.
  • Use of antibiotics in the last 4 weeks.
  • Use of probiotics in the last 2 weeks.
  • Organic gastrointestinal disease, including inflammatory bowel disease (IBD), coeliac disease and diverticulitis.
  • Participant has known mechanical obstruction of the GI tract.
  • Participant has diabetes.
  • Participant has any hepatic disease.
  • Participant has any disease of the CNS.
  • Participant has had previous abdominal or colorectal surgery including appendectomy, cholecystectomy, and hysterectomy.
  • Participant has intake of ERME for 2 weeks before the study.

Key Trial Info

Start Date :

March 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2022

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT04873466

Start Date

March 1 2021

End Date

March 1 2022

Last Update

September 23 2022

Active Locations (1)

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The Functional Gut Clinic

Manchester, Greater Manchester, United Kingdom, M2 4NG