The Effects of Enzyme-rich Malt Extract on Chronic Constipation

Not Applicable

Completed

• Conditions: Constipation; Quality of Life; Methane Production
• Interventions: Dietary Supplement: Enzyme-rich malt extract

• Registration Number: NCT04873466
• Lead Sponsor: The Functional Gut Clinic

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 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.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-05
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enzyme-rich malt extract	Enzyme-rich malt extract	Enzyme-rich malt extract (15 ml b.i.d with food)

Primary Outcome Measures

Name	Time	Method
Change in constipation score	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 Outcome Measures

Name	Time	Method
Change in breath methane levels	35 days	fasting breath methane levels (ppm)
Change in flatulence	35 days	according to daily visual analog scale
Change in bloating	35 days	according to daily visual analog scale
Change in abdominal pain	35 days	according to daily visual analog scale
Change in stool frequency	35 days	according to number of weekly bowel movements

Trial Locations

Locations (1)

The Functional Gut Clinic; 🇬🇧 Manchester, Greater Manchester, United Kingdom