The Effects of Enzyme-rich Malt Extract on Chronic Constipation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Constipation, Quality of Life, Methane Production

Intervention / Treatment
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* Dietary Supplement: Enzyme-rich malt extract


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective Cohort
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enzyme-rich malt extract<br>Enzyme-rich malt extract (15 ml b.i.d with food) | Dietary Supplement: Enzyme-rich malt extract<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stool frequency | according to number of weekly bowel movements | 35 days | 
| Change in breath methane levels | fasting breath methane levels (ppm) | 35 days | 
| Change in bloating | according to daily visual analog scale | 35 days | 
| Change in abdominal pain | according to daily visual analog scale | 35 days | 
| Change in flatulence | according to daily visual analog scale | 35 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Constipation