The Functional Gut Clinic
Manchester, Greater Manchester, M2 4NG, United Kingdom
NCT Number: NCT04873466
Participants with constipation will take enzyme-rich malt extract for 4 weeks whilst completing a daily bowel habit diary before and during intervention.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Manchester, Greater Manchester, M2 4NG, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 35 days
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
according to number of weekly bowel movements
Time frame: 35 days
fasting breath methane levels (ppm)
Time frame: 35 days
according to daily visual analog scale
Time frame: 35 days
according to daily visual analog scale
Time frame: 35 days
according to daily visual analog scale
The Functional Gut Clinic
Other
The Effects of Enzyme-rich Malt Extract on Symptoms of Chronic Constipation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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