The Effects of Enzyme-rich Malt Extract on Chronic Constipation

NCT ID: NCT04873466

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-03-01

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.

Conditions

Constipation; Quality of Life; Methane Production

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enzyme-rich malt extract

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

Group Type: EXPERIMENTAL

Enzyme-rich malt extract

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Functional Gut Clinic

OTHER

Sponsor Role: lead

Responsible Party

Jordan Haworth

Clinical Physiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Functional Gut Clinic

Manchester, Greater Manchester, United Kingdom

Countries

United Kingdom

Related Links

https://functionalgutdiagnostics.com/clinical-research/

Related Info

Other Identifiers

FGC-20-004

Identifier Type: -

Identifier Source: org_study_id