Status:
COMPLETED
The Efficacy of a Probiotic for Functional Constipation (FC)
Lead Sponsor:
The Archer-Daniels-Midland Company
Collaborating Sponsors:
Analyze & Realize
Conditions:
Functional Constipation
Eligibility:
All Genders
18-65 years
Phase:
NA
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 me...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Planning travel for \>1 week during the study duration
- Anticipated major changes in diet or exercise during the study
- Pregnant or lactating or planned to become pregnant during the study period
- Smoking \> 5 cigarettes per week
- An irregular diet, an abnormal sleep cycle, or other lifestyle abnormalities, as per investigator judgement
- Individuals who, in the opinion of the investigator, are considered to be incompliant clinical attendees or unlikely for any reason to be able to complete the trial as required
- Clinically relevant deviation of screening laboratory parameters at V1
Key Trial Info
Start Date :
October 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2024
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06083311
Start Date
October 19 2023
End Date
December 17 2024
Last Update
April 9 2025
Active Locations (1)
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1
analyze & realize GmbH
Berlin, Germany, 10369