CompletedNot Applicable

The Efficacy of a Probiotic for Functional Constipation (FC)

Germany55 participantsStarted 2023-10-19

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexALL

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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

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

What they're measuring

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

Timeframe: Baseline (V2), Day 28 (V3)

Trial details

NCT IDNCT06083311

SponsorThe Archer-Daniels-Midland Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-17

View on ClinicalTrials.gov More Functional Constipation trials