The Effects of Enzyme-rich Malt Extract on Chronic Constipation

The Functional Gut Clinic20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Constipation Quality of Life Methane Production

Interventions

Enzyme-rich malt extractDIETARY_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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Functional Gut Clinic

Manchester, Greater Manchester, United Kingdom

Outcomes

Primary Outcomes

Change in constipation score

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

Time frame: 35 days

Secondary Outcomes

Change in stool frequency

according to number of weekly bowel movements

Time frame: 35 days

Change in breath methane levels

fasting breath methane levels (ppm)

Time frame: 35 days

Change in bloating

according to daily visual analog scale

Time frame: 35 days

Change in abdominal pain

according to daily visual analog scale

Time frame: 35 days

Change in flatulence

according to daily visual analog scale

Time frame: 35 days

Data from ClinicalTrials.gov

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