Functional ConstipationSLOGNCT06083311
The Efficacy of a Probiotic for Functional Constipation (FC)
A study testing Probiotic in people with Functional Constipation, run by The Archer-Daniels-Midland Company at 1 site in Germany.
Trial summary
Investigate the effect of a probiotic (live bacteria) in individuals with functional constipation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- 19 Oct 2023to 17 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Triple-blinded, Placebo-controlled, Parallel Group Pilot Study, to Assess the Effect of Probiotic on Functional Constipation and Gut Microbiology
Investigate the effect of a probiotic (live bacteria) in individuals with functional constipation.
Read the 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.
- Conditions
- Functional Constipation
- Being tested
- Probiotic, Placebo
- Keywords
- Probiotic, GI microbiome, Lactobacillus, Bifidobacterium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary 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
PlaceboDietary supplement
Participants in this arm will receive an equivalent placebo for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Participants in this arm will receive an equivalent placebo for 28 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Difference in change in Cleveland Clinic Constipation score (CCCS) (total) from 2 weeks after V2 to study end (V3) between verum and placebo groups. Higher scores in the CCCS indicate worse constipation symptoms (Max score: 30)
Measured: Baseline (V2), Day 14
Difference in change in Patient Assessment of Constipation - Quality of Life score (total) from V2 to V3
Difference in change in Patient Assessment of Constipation - Quality of Life (PAC-QOL) score (total) from V2 to V3. Higher scores in the PAC-QOL indicate worse constipation symptoms (Max Score: 112)
Measured: 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
Difference in change in Patient Assessment of Constipation - Quality of Life (PAC-QOL) score (total) from 2 weeks after V2 to V3. Higher scores in the PAC-QOL indicate worse constipation symptoms (Max Score: 112)
Measured: Baseline (V2), Day 14
Difference in Patient Assessment of Constipation - Quality of Life domain score from V2 to V3
Difference in change in Patient Assessment of Constipation - Quality of Life (PAC-QOL) domain scores (total) from V2 to V3. Higher scores in the PAC-QOL domain scores indicate worse constipation symptoms (varying questions in each domain, each question scored 0 - 4 on Likert scale)
Measured: 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
Difference in change in Patient Assessment of Constipation - Quality of Life (PAC-QOL) domain scores (total) from 2 weeks after V2 to V2. Higher scores in the PAC-QOL domain indicate worse constipation symptoms (varying questions in each domain, each question scored 0 - 4 on Likert scale)
Measured: Baseline (V2), Day 14
Difference in change in total reflux symptoms score from V2 to V3
Difference in (total) reflux questionnaire scores from V2 to V3. Higher scores in the reflux questions indicate worse reflux symptoms. Max score 10.
Measured: Baseline (V2), Day 28 (V3)
Difference in change in total reflux symptoms score at 2 weeks after V2, compared to V2
Difference in (total) reflux questionnaire scores from 2 weeks after V2 to V2. Higher scores in the reflux questions indicate worse reflux symptoms. Max score 10.
Measured: Baseline (V2), Day 14
Difference in change in reflux symptoms sub-scale score (i.e. individual items) from V2 to V3
Difference in (subscale) reflux questionnaire scores from V2 to V3. Higher scores in the reflux questions indicate worse reflux symptoms. Each question is a Likert scale ranging from 1-5. Max score is 5.
Measured: Baseline (V2), Day 28 (V3)
Difference in change in reflux symptoms sub-scale score (i.e. individual items) at 2 weeks after V2, compared to V2
Difference in (subscale) reflux questionnaire scores from 2 weeks after V2 to V2. Higher scores in the reflux questions indicate worse reflux symptoms. Each question is a Likert scale ranging from 1-5. Max score is 5.
Measured: 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
Proportion of stool in each Bristol Stool Form Scale (BSFS) category at 1, 2, 3 week(s) after V2 and at V3, each compared to V2. BSFS categories range from 1 - 7, with 1 representing hard stool and 7 representing liquid stool.
Measured: Baseline (V2), Day 7, Day 14, Day 21 and Day 28
Difference in change in mean weekly stool frequency at 1, 2, 3 week(s) after V2 and at V3, each compared to V2
Difference in change in mean weekly number of bowel movements at 1, 2, 3 week(s) after V2 and at V3, each compared to V2.
Measured: 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
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
Measured: 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
Difference in change of the weekly average degree of straining (VAS) at 1, 2, 3 week(s) after V2 and at V3, each compared to V2. Straining calculated on a 5-point Likert Scale, where 1 is no straining and 5 is very severe straining
Measured: Baseline (V2), Day 7, Day 14, Day 21 and Day 28
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
Difference in change of the weekly average defecation/rectal pain at 1, 2, 3 week(s) after V2 and at V3, each compared to V2. Defecation/Rectal pain calculated on a 5-point Likert Scale, where 1 is no painand 5 is very severe pain
Measured: Baseline (V2), Day 7, Day 14, Day 21 and Day 28
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
Difference in the weekly average self-assessment of complete bowel emptying at 1, 2, 3 week(s) after V2 and at V3, each compared to V2. Self assessment of complete bowel emptying conducted with a 'yes' or 'no' question
Measured: Baseline (V2), Day 7, Day 14, Day 21 and Day 28
Difference in weekly average use of laxatives at 1, 2, 3 week(s) after V2 and at V3, each compared to V2
Difference in weekly average use of laxatives at 1, 2, 3 week(s) after V2 and at V3, each compared to V2
Measured: 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
Difference in weekly average need for digital assistance at 1, 2, 3 week(s) after V2 and at V3, each compared to V2
Measured: 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
Difference in short chain fatty acids (SCFA) in stool samples collected prior to V2 and prior to V3.
Measured: 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
Difference in findings of microbiome assessment using metagenomics techniques of stool samples collected prior to V2 and prior to V3
Measured: Baseline (V2), Day 28 (V3)
Difference in findings of targeted metabolomic analysis of stool samples collected prior to V2 and prior to V3
Difference in findings of targeted metabolomic analysis of stool samples collected prior to V2 and prior to V3
Measured: Baseline (V2), Day 28 (V3)
Percentage of subjects with matching records of blinded assessment concern-ing the IP type they received (verum, placebo) and the actual IP assignment
Percentage of subjects with matching records of blinded assessment concern-ing the IP type they received (verum, placebo) and the actual IP assignment
Measured: Day 28 (V3)
Assessment of benefit by subject and investigator at V3 (4 point categorical scale)
Assessment of benefit by subject and investigator at V3. 4 point scale, where 1 = poor and 4 = very good
Measured: Day 28 (V3)
Assessment of the number of adverse events between the intervention and placebo
Assessment of the number of adverse events between the intervention and placebo
Measured: Day 28 (V3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start19 Oct 2023
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Archer-Daniels-Midland Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083311
- Sponsor's protocol ID
- CTB2022TN103
- Acronym
- SLOG
- Status last verified
- Mar 2025
- First submitted
- 9 Oct 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Triple-blinded, Placebo-controlled, Parallel Group Pilot Study, to Assess the Effect of Probiotic on Functional Constipation and Gut Microbiology
- ClinicalTrials.gov ID
- NCT06083311
- Acronym / sponsor ID
- SLOG / CTB2022TN103
- Conditions
- Functional Constipation
- Keywords
- Probiotic, GI microbiome, Lactobacillus, Bifidobacterium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- The Archer-Daniels-Midland CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticParticipants 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 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants in this arm will receive an equivalent placebo for 28 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticParticipants 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 |
| PlaceboParticipants in this arm will receive an equivalent placebo for 28 days | Dietary supplement | Placebo |
Primary outcome
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)
23 secondary outcomes
Difference in change in Cleveland Clinic Constipation score (total) at 2 week(s) after V2, compared to V2
Time frame: Baseline (V2), Day 14
Difference in change in Patient Assessment of Constipation - Quality of Life score (total) from V2 to V3
Time frame: 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
Time frame: Baseline (V2), Day 14
Difference in Patient Assessment of Constipation - Quality of Life domain score from V2 to V3
Time frame: 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
Time frame: Baseline (V2), Day 14
Difference in change in total reflux symptoms score from V2 to V3
Time frame: Baseline (V2), Day 28 (V3)
Difference in change in total reflux symptoms score at 2 weeks after V2, compared to V2
Time frame: Baseline (V2), Day 14
Difference in change in reflux symptoms sub-scale score (i.e. individual items) from V2 to V3
Time frame: Baseline (V2), Day 28 (V3)
Difference in change in reflux symptoms sub-scale score (i.e. individual items) at 2 weeks after V2, compared to V2
Time frame: 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
Time frame: Baseline (V2), Day 7, Day 14, Day 21 and Day 28
Difference in change in mean weekly stool frequency at 1, 2, 3 week(s) after V2 and at V3, each compared to V2
Time frame: 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
Time frame: 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
Time frame: Baseline (V2), Day 7, Day 14, Day 21 and Day 28
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
Time frame: Baseline (V2), Day 7, Day 14, Day 21 and Day 28
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
Time frame: Baseline (V2), Day 7, Day 14, Day 21 and Day 28
Difference in weekly average use of laxatives at 1, 2, 3 week(s) after V2 and at V3, each compared to V2
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (V2), Day 28 (V3)
Difference in findings of targeted metabolomic analysis of stool samples collected prior to V2 and prior to V3
Time frame: Baseline (V2), Day 28 (V3)
Percentage of subjects with matching records of blinded assessment concern-ing the IP type they received (verum, placebo) and the actual IP assignment
Time frame: Day 28 (V3)
Assessment of benefit by subject and investigator at V3 (4 point categorical scale)
Time frame: Day 28 (V3)
Assessment of the number of adverse events between the intervention and placebo
Time frame: Day 28 (V3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Functional Constipation, run by The Archer-Daniels-Midland Company at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in change in Cleveland Clinic Constipation score (total) from baseline (V2) to study end (V3) (time frame: Baseline (V2), Day 28 (V3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.