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The Effects of Enzyme-rich Malt Extract on Chronic Constipation

Primary Purpose

Constipation, Quality of Life, Methane Production

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Enzyme-rich malt extract
Sponsored by
The Functional Gut Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Constipation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Functional Gut Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enzyme-rich malt extract

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in stool frequency
according to number of weekly bowel movements
Change in breath methane levels
fasting breath methane levels (ppm)
Change in bloating
according to daily visual analog scale
Change in abdominal pain
according to daily visual analog scale
Change in flatulence
according to daily visual analog scale

Full Information

First Posted
April 30, 2021
Last Updated
September 22, 2022
Sponsor
The Functional Gut Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04873466
Brief Title
The Effects of Enzyme-rich Malt Extract on Chronic Constipation
Official Title
The Effects of Enzyme-rich Malt Extract on Symptoms of Chronic Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Functional Gut Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Quality of Life, Methane Production
Keywords
Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective Cohort
Masking
None (Open Label)
Masking Description
Open label, single arm
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enzyme-rich malt extract
Arm Type
Experimental
Arm Description
Enzyme-rich malt extract (15 ml b.i.d with food)
Intervention Type
Dietary Supplement
Intervention Name(s)
Enzyme-rich malt extract
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in constipation score
Description
according to Knowels-Eccersley-Scott Symptom (KESS) score (likert scale of 0-3/4 with maximum score 39). Higher score = more severe
Time Frame
35 days
Secondary Outcome Measure Information:
Title
Change in stool frequency
Description
according to number of weekly bowel movements
Time Frame
35 days
Title
Change in breath methane levels
Description
fasting breath methane levels (ppm)
Time Frame
35 days
Title
Change in bloating
Description
according to daily visual analog scale
Time Frame
35 days
Title
Change in abdominal pain
Description
according to daily visual analog scale
Time Frame
35 days
Title
Change in flatulence
Description
according to daily visual analog scale
Time Frame
35 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The Functional Gut Clinic
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M2 4NG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://functionalgutdiagnostics.com/clinical-research/
Description
Related Info

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The Effects of Enzyme-rich Malt Extract on Chronic Constipation

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