Evaluation of Acacia Gum on Microbiome and Bowel Function in Participants With Chronic Constipation

Not Applicable

Completed

• Conditions: Constipation
• Interventions: Dietary Supplement: acacia gum

• Registration Number: NCT04382456
• Lead Sponsor: Alpinia Laudanum GmbH

Brief Summary

Proof of concept study to investigate the impact of a food supplement consisting of Acacia gum on changes of gut microbiota and production of short chain fatty acids. Additionally, safety, tolerability and parameters of bowel function (stool frequency, stool consistency and gastrointestinal symptoms) will be assessed during the study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-11
• Study Start: 2020-06-01
• Status Verified: 2020-08
• Primary Completion: 2020-09-07
• Study Completion: 2020-09-07
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• Healthy subjects without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility

• Constipation defined as an average of 2 - 3 stools per week (which needs to be confirmed during a prospective run-in phase)

• At least one of the following criteria:

  • straining during more than 25% of defecations
  • lumpy or hard stools (Bristol Stool Form Scale 1 or 2) present more than 25% of defecations
  • sensation of incomplete evacuation in more than 25% of defecations
  • sensation of anorectal obstruction/ blockage in more than 25% of defecations
  • manual manoeuvre to facilitate more than 25% of defecations (such as digital evacuation or support from pelvic floor)

• Criteria of constipation for at least the previous 3 months

• BMI 18.5 - 30 kg/m2

• Stable body weight (+/- 5%) in the last 3 months (self-reported)

• Willing to maintain normal background dietary habits & physical activity levels throughout the study period

• Written consent to participate in the study

Exclusion Criteria

• Relevant history or presence of any severe medical disorder, potentially interfering with this study in the investigator's judgement (e.g. mal absorption, food intolerance or allergy, chronic gastro-intestinal diseases (e.g. Morbus Crohn, Colitis Ulcerosa), chronic kidney or liver disease, severe depression, immunological disorders, severe cardiovascular disease, diabetes, acute malignant disease within last 3 years except basal cell carcinoma of the skin)

• Prior abdominal surgery which may present a risk for the subject or confound the study results (according to the investigator's opinion)

• Currently (or in the last 3 months) suffering from significant stress, anxiety or depression which, in the subjects opinion, interferes with normal daily life (e.g. has the subject missed days of work due to these conditions) and/or which could be responsible for gastrointestinal problems

• Exclusively vegan or vegetarian diet (high fiber content)

• Regular laxative use at least once per week

• Use of hypolipidaemic drugs (e.g. statins, fibrates, resins, ezetimibe, niacin)

• Subject under prescription for medication or taking dietary supplements possibly interfering with this study (such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries, use of PPIs, bismuth salts and/or H2-antagonists, fibers etc.) within 2 weeks prior to study start or during the study; Stable medication (more than 3 months) for hypertension or thyroid gland is allowed.

• Use of pre- and probiotic supplements

• Subjects consuming

  • food or drinks claimed as 'probiotic', or 'prebiotic more than once weekly
  • food or drinks claimed as 'rich in fiber' (including specific milk products) more than 3 times per week
  • more than 3 portions of fruits and vegetables (sum) per day

• Smoker

• Intake of antibiotics in the last 4 weeks

• Pregnancy or breastfeeding (also exclude recent pregnancy in the last 3 months). A pregnancy test will be conducted during screening and visits 1 - 3.

• Currently or recently (within 3 months of study entry) taking any medication, which in the opinion of the investigator, could interfere with the outcome of the study, e.g. opioids, anti-psychotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
acacia gum	acacia gum	-

Primary Outcome Measures

Name	Time	Method
Gut microbiota	day 1, day 43 and day 71	Composition and diversity (Shannon index), Lactobacillogenic and bifidogenic level, Distribution of bacterial taxa at the phylum, family and genus level, Shifts of specific bacterial taxa

Secondary Outcome Measures

Name	Time	Method
Stool consitency	day -14 (run-in phase) until day 70 (end of follow up)	consistency will be assessed via Bristol Stool Form Scale
Gastrointestinal symptoms	day -14 (run-in phase) until day 70 (end of follow up)	Global Gastrointestinal Discomfort Assessment (PAC-SYM), single gastrointestinal symptoms (flatulence, rumbling (i.e. borborygmi)), layative use
Blood biomarker	day 1, day 43 and day 71	Lipid profile (total, HDL- and LDL- cholesterol and triglycerides) Blood glucose Electrolytes and minerals (plasma sodium, potassium and calcium) SCFA (short chain fatty acids) (optional) Cytokines: IL-10 \& IL-6 (optional)
Stool frequency	day -14 (run-in phase) until day 70 (end of follow up)	frequency per week will be assessed via diary
Stool biomarker	day 1, day 43 and day 71	SCFA (short chain fatty acids) Zonulin Calprotectin (optional) Secretory IgA (optional) Beta-defensin (optional) Bile acids (optional) Nitric oxide (optional)

Trial Locations

Locations (1)

BioTeSys GmbH; 🇩🇪 Esslingen, Germany