A Randomised, Triple-blinded, Placebo-controlled, Parallel Group Pilot Study, to Assess the Effect of Probiotic on Functional Constipation and Gut Microbiology

The Archer-Daniels-Midland Company1 site in 1 country55 target enrollmentOctober 19, 2023

ConditionsFunctional Constipation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Functional Constipation
Sponsor: The Archer-Daniels-Midland Company
Enrollment: 55
Locations: 1
Primary Endpoint: Difference in change in Cleveland Clinic Constipation score (total) from baseline (V2) to study end (V3)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Investigate the effect of a probiotic (live bacteria) in individuals with functional constipation.

Detailed Description

This study aims to investigate the safety and efficacy of live bacteria on defecation parameters in individuals with Functional Constipation. The trial will be run in Germany and will recruit adult men and women meeting the ROME-IV criteria for functional constipation.

Registry

clinicaltrials.gov

Start Date

October 19, 2023

End Date

December 17, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Archer-Daniels-Midland Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males (at least 30% of total number of subjects) and females ≥ 18 years and ≤65 years old
•Body Mass Index (BMI) 18.5 - 30.0 kg/m2
•Fulfilment of the Rome IV FC diagnostic criteria at V1 and V2
•Self-reported average stool frequency of 3 or less bowel movements per week
•Self-reported average stool consistency of type 1-4 on the Bristol Stool Form Scale
•Cleveland Clinic Constipation Score \> 8 at V1
•Readiness not to use any treatment/supplementation for complaints related to constipation (e.g. prokinetics, laxatives, enemas) during the study; exception: glycerol suppository and if it provides no benefit, participants are allowed to take oral laxatives (see section 0)
•Readiness and ability to comply with and perform the procedures requested by the protocol
•If receiving proton pump inhibitors (PPI), anticipated to continue PPI therapy for the duration of the trial
•Readiness not to have any change in habitual diet or exercise patterns over the study period

Exclusion Criteria

•Clinically relevant (as per investigators judgement) self-reported chronic disease of the gastrointestinal tract (e.g. irritable bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease, diverticulitis, malabsorption disorder), neurological, cardiovascular, endocrine/reproductive, renal, or other chronic diseases likely to affect gut motility
•Prior abdominal surgery in the past 3 years (except for laparoscopic appendectomy and cholecystectomy and other minor laparoscopic surgeries, as per investigator judgement, that are allowed)
•Ongoing regular use of products that (in the investigator's opinion) are known to cause constipation or change gastric motility (e.g. iron; opioids; sucralfate; 5-HT3 antagonists (e.g. ondansetron); antacids with magnesium, calcium, or aluminum; anticholinergic agents; calcium supplements; trycyclic antidepressants; systemic steroids)
•Any subjects with use of PPI within the last 8 weeks prior to Visit 1 (exception: continuous use for ≥ 8 week before Visit 1 is allowed)
•Post-menopausal women, defined as \>12 months after the last menstrual bleeding and not using hormonal contraception
•Women ≥ 50 years using hormonal contraception
•ALARM features in the past 3 months prior to study (e.g. fever, unintentional weight loss ≥5 kg, blood in stool, vomiting) and moderate or severe anorectal problems (e.g. rectal bleeding, pelvic organ prolapse, anal fissures)
•Previously diagnosed lactose intolerance, gluten intolerance, cow's milk allergy and/or soya-allergy
•Known allergy or hypersensitivity to any ingredients of the investigational product
•Consumption of biotic supplements (probiotics, prebiotics, synbiotics or post-biotics) within 2 weeks prior to Visit 1 and during the study

Outcomes

Primary Outcomes

Difference in change in Cleveland Clinic Constipation score (total) from baseline (V2) to study end (V3)

Time Frame: Baseline (V2), Day 28 (V3)

Difference in change in Cleveland Clinic Constipation score (CCCS) (total) from baseline (V2) to study end (V3) between verum and placebo groups. Higher scores in the CCCS indicate worse constipation symptoms. (Max score: 30)

Secondary Outcomes

Difference in change in total reflux symptoms score at 2 weeks after V2, compared to V2(Baseline (V2), Day 14)
Difference in proportion of stools in different Bristol Stool Form Scale categories (1-2, 3-4, 5-7) at 1, 2, 3 week(s) after V2 and at V3, each compared to V2(Baseline (V2), Day 7, Day 14, Day 21 and Day 28)
Difference in change in mean weekly number of spontaneous bowel movements (without assistance/ medication) at 1, 2, 3 week(s) after V2 and at V3, each compared to V2(Baseline (V2), Day 7, Day 14, Day 21 and Day 28)
Difference in short chain fatty acids (SCFA) in stool samples collected prior to V2 and prior to V3(Baseline (V2), Day 28 (V3))
Difference in findings of microbiome assessment using metagenomics techniques of stool samples collected prior to V2 and prior to V3(Baseline (V2), Day 28 (V3))
Assessment of benefit by subject and investigator at V3 (4 point categorical scale)(Day 28 (V3))
Difference in change in Cleveland Clinic Constipation score (total) at 2 week(s) after V2, compared to V2(Baseline (V2), Day 14)
Difference in change in Patient Assessment of Constipation - Quality of Life score (total) from V2 to V3(Baseline (V2), Day 28 (V3))
Difference in change in total reflux symptoms score from V2 to V3(Baseline (V2), Day 28 (V3))
Difference in change in reflux symptoms sub-scale score (i.e. individual items) from V2 to V3(Baseline (V2), Day 28 (V3))
Difference in change in Patient Assessment of Constipation - Quality of Life score (total) at 2 week(s) after V2, compared to V2(Baseline (V2), Day 14)
Difference in change in Patient Assessment of Constipation - Quality of Life domain scores at 2 week(s) after V2, compared to V2(Baseline (V2), Day 14)
Difference in Patient Assessment of Constipation - Quality of Life domain score from V2 to V3(Baseline (V2), Day 28 (V3))
Difference in the weekly self-assessment of complete bowel emptying at 1, 2, 3 week(s) after V2 and at V3, each compared to V2(Baseline (V2), Day 7, Day 14, Day 21 and Day 28)
Difference in change in reflux symptoms sub-scale score (i.e. individual items) at 2 weeks after V2, compared to V2(Baseline (V2), Day 14)
Difference in change in mean weekly stool frequency at 1, 2, 3 week(s) after V2 and at V3, each compared to V2(Baseline (V2), Day 7, Day 14, Day 21 and Day 28)
Difference in change of the weekly degree of straining (VAS) at 1, 2, 3 week(s) after V2 and at V3, each compared to V2(Baseline (V2), Day 7, Day 14, Day 21 and Day 28)
Difference in findings of targeted metabolomic analysis of stool samples collected prior to V2 and prior to V3(Baseline (V2), Day 28 (V3))
Difference in change of the weekly defecation/ rectal pain (VAS) at 1, 2, 3 week(s) after V2 and at V3, each compared to V2(Baseline (V2), Day 7, Day 14, Day 21 and Day 28)
Difference in weekly need for digital assistance at 1, 2, 3 week(s) after V2 and at V3, each compared to V2(Baseline (V2), Day 7, Day 14, Day 21 and Day 28)
Percentage of subjects with matching records of blinded assessment concern-ing the IP type they received (verum, placebo) and the actual IP assignment(Day 28 (V3))
Assessment of the number of adverse events between the intervention and placebo(Day 28 (V3))
Difference in weekly average use of laxatives at 1, 2, 3 week(s) after V2 and at V3, each compared to V2(Baseline (V2), Day 7, Day 14, Day 21 and Day 28)