The Effects of Enzyme-rich Malt Extract on Chronic Constipation
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 30, 2021
CompletedFirst Posted
Study publicly available on registry
May 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedSeptember 23, 2022
September 1, 2022
10 months
April 30, 2021
September 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Change in stool frequency
35 days
Change in breath methane levels
35 days
Change in bloating
35 days
Change in abdominal pain
35 days
Change in flatulence
35 days
Study Arms (1)
Enzyme-rich malt extract
EXPERIMENTALEnzyme-rich malt extract (15 ml b.i.d with food)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Functional Gut Clinic
Manchester, Greater Manchester, M2 4NG, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open label, single arm
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Physiologist
Study Record Dates
First Submitted
April 30, 2021
First Posted
May 5, 2021
Study Start
March 1, 2021
Primary Completion
December 31, 2021
Study Completion
March 1, 2022
Last Updated
September 23, 2022
Record last verified: 2022-09