The Effects of Enzyme-rich Malt Extract on Chronic Consti... | NCT04873466

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

NCT04873466

Sponsor

The Functional Gut Clinic

Status

Completed

Last Update Posted

Sep 23, 2022Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Constipation
Quality of Life
Methane Production

Interventions

Enzyme-rich malt extract

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Mar 1, 2022Actual

First Submitted Date

Apr 30, 2021

First Submission Date that Met QC Criteria

Apr 30, 2021

First Posted Date

May 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2022

Last Update Posted Date

Sep 23, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enzyme-rich malt extract	Experimental	Enzyme-rich malt extract (15 ml b.i.d with food)	Dietary Supplement: Enzyme-rich malt extract

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enzyme-rich malt extract	Dietary Supplement	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change in stool frequency	according to number of weekly bowel movements	35 days
Change in breath methane levels	fasting breath methane levels (ppm)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Functional Gut Clinic		Manchester	Greater Manchester	M2 4NG	United Kingdom

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003248	Constipation

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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