The Efficacy of a Probiotic for Functional Constipation (FC)

NCT06083311 | Completed

• 1 other identifier: CTB2022TN103
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Functional Constipation

Keywords

Probiotic; GI microbiome; Lactobacillus; Bifidobacterium

Outcome Measures

Primary Outcomes (1)

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

  Baseline (V2), Day 28 (V3)

Secondary Outcomes (23)

• 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 Patient Assessment of Constipation - Quality of Life score (total) 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 change in Patient Assessment of Constipation - Quality of Life domain scores at 2 week(s) after V2, compared to V2

  Baseline (V2), Day 14

Study Arms (2)

Probiotic

EXPERIMENTAL

Participants in this arm will receive a daily dose of 3x10\^9 Colony Forming Units (CFU) of a live bacterium, corresponding to 1 capsules daily for 28 days

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Participants in this arm will receive an equivalent placebo for 28 days

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Participants in this arm will receive a daily dose of 3x10\^9 Colony Forming Units (CFU) of a live bacterium, corresponding to 1 capsules daily for 28 days

Probiotic

Placebo DIETARY_SUPPLEMENT

Participants in this arm will receive an equivalent placebo for 28 days

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Women:
• If sexually active, commitment to use contraception methods
• negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
• Generally, in the opinion of investigator, healthy individuals (e.g. no heart failure, no malignancy) Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.

You may not qualify if:

• 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
• Regular consumption of fibre supplements and/or laxatives more than 1x a week
• Use of laxatives within 48 hrs prior to Visit 1
• Use of antibiotic within 4 weeks prior to Visit 1 and during the study
• Ongoing alcohol, drug, or medication abuse
• Participation in other clinical trials within 4 weeks prior to Visit 1 and during the study

Sponsors & Collaborators

• The Archer-Daniels-Midland Company: lead
• Analyze & Realize: collaborator

Study Sites (1)

analyze & realize GmbH

Berlin, 10369, Germany

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple Blind Study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 16, 2023
• Study Start: October 19, 2023
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-03

Locations

DE (1)