The Effects of Enzyme-rich Malt Extract on Chronic Constipation

The Functional Gut Clinic

Status

Completed

Conditions

Methane Production

Quality of Life

Constipation

Treatments

Dietary Supplement: Enzyme-rich malt extract

Study type

Interventional

Funder types

Other

Identifiers

NCT04873466

FGC-20-004

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.