The Effects of Enzyme-rich Malt Extract on Chronic Constipation

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04873466
• Other study ID #: FGC-20-004
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: September 2022
• Source: The Functional Gut Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	The Functional Gut Clinic	Manchester	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
The Functional Gut Clinic

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in stool frequency	according to number of weekly bowel movements	35 days
Secondary	Change in breath methane levels	fasting breath methane levels (ppm)	35 days
Secondary	Change in bloating	according to daily visual analog scale	35 days
Secondary	Change in abdominal pain	according to daily visual analog scale	35 days
Secondary	Change in flatulence	according to daily visual analog scale	35 days

External Links

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