Skip to main content
OpenTrials
Completed

NCT Number: NCT04873466

The Effects of Enzyme-rich Malt Extract on Chronic Constipation

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Functional Gut Clinic

Manchester, Greater Manchester, M2 4NG, United Kingdom

About this study

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 a diagnosis constipation according to the Knowles-Eccersley-Scott Score (KESS). Participants will receive intervention with a food supplement enzyme-rich malt extract (ERME) at a dose of 15ml twice daily with food.

Before intervention commences, participants will complete baseline breath samples and a 7 day stool diary to assess stool frequency and consistency.

Participants will then receive the ERME as instructed and continue to complete a bowel diary. Then at 4 weeks since starting the intervention, participants will provide another breath sample and complete another set of breath samples.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Enzyme-rich malt extract

Dietary Supplement

Enzyme-rich malt extract (ERME) is a by-product of the malting process in which the cereal grain barley is dried. The ingredients are 100% barley malt extract. It smells and tastes sweet, with a runny jam-like texture. Malt extract has been used as a food stuff in baking and cookery for many years, but ERME is extracted by means which retains more active enzymes, such as amylase.

Primary outcomes

  1. Change in constipation score

    Time frame: 35 days

    according to Knowels-Eccersley-Scott Symptom (KESS) score (likert scale of 0-3/4 with maximum score 39). Higher score = more severe

Secondary outcomes

  1. Change in stool frequency

    Time frame: 35 days

    according to number of weekly bowel movements

  2. Change in breath methane levels

    Time frame: 35 days

    fasting breath methane levels (ppm)

  3. Change in bloating

    Time frame: 35 days

    according to daily visual analog scale

  4. Change in abdominal pain

    Time frame: 35 days

    according to daily visual analog scale

  5. Change in flatulence

    Time frame: 35 days

    according to daily visual analog scale

Sponsors and collaborators

Lead sponsor

The Functional Gut Clinic

Other

Registry information

Official study title

The Effects of Enzyme-rich Malt Extract on Symptoms of Chronic Constipation

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 5, 2021
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.