The Effects of Enzyme-rich Malt Extract on Chronic Constipation

The Effects of Enzyme-rich Malt Extract on Symptoms of 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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Constipation; Methane Production
• Intervention / Treatment: Dietary supplement: Enzyme-rich malt extract

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M2 4NG
      • The Functional Gut Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Enzyme-rich malt extract; Enzyme-rich malt extract (15 ml b.i.d with food)

Dietary supplement: Enzyme-rich malt extract; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Functional Gut Clinic

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: FGC-20-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No