The Effects of Enzyme-rich Malt Extract on Chronic Constipation

Sponsor

The Functional Gut Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04873466

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Constipation Quality of Life Methane Production	Dietary Supplement: Enzyme-rich malt extract	N/A

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, quality of life questionnaire (WHOQOL-BREF), 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 breath samples and quality of life questionnaire (WHOQOL-BREF).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective CohortProspective Cohort

Masking:

None (Open Label)

Masking Description:

Open label, single arm

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Reduction in KESS (constipation) [35 days]

Secondary Outcome Measures

Increase in stool frequency [35 days]
Reduction in breath methane levels [35 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Functional Gut Clinic	Manchester	Greater Manchester	United Kingdom	M2 4NG

Sponsors and Collaborators

The Functional Gut Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Jordan Haworth, Clinical Physiologist, The Functional Gut Clinic

ClinicalTrials.gov Identifier:

NCT04873466

Other Study ID Numbers:

FGC-20-004

First Posted:

May 5, 2021

Last Update Posted:

May 5, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jordan Haworth, Clinical Physiologist, The Functional Gut Clinic

Constipation

Additional relevant MeSH terms:

Constipation

Study Results

No Results Posted as of May 5, 2021