Constipation, Methane Production, Quality of Life
Conditions
Keywords
Constipation
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.
Interventions
DIETARY_SUPPLEMENTEnzyme-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.
Sponsors
The Functional Gut Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label, single arm
Intervention model description
Prospective Cohort
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in constipation score | 35 days | according to Knowels-Eccersley-Scott Symptom (KESS) score (likert scale of 0-3/4 with maximum score 39). Higher score = more severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in stool frequency | 35 days | according to number of weekly bowel movements |
| Change in breath methane levels | 35 days | fasting breath methane levels (ppm) |
| Change in bloating | 35 days | according to daily visual analog scale |
| Change in abdominal pain | 35 days | according to daily visual analog scale |
| Change in flatulence | 35 days | according to daily visual analog scale |
Countries
United Kingdom
Outcome results
None listed