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The primary objective is to determine the change in frequency of complete spontaneous bowel movements (CSBMs) after 4 weeks of oral supplementation with Lactobacillus gasseri DSM 27123 in healthy adult women with functional constipation.
Subjects to complete study diaries, number of SBM, CSBM, form of faeces (according to the Bristol Stool Form scale), pain during defecation (according to the visual analogue scale [VAS] 0-100), time spent at each evacuation, episodes of faecal incontinence, number of ingested capsules of investigational product will be recorded daily by the subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus gasseri | Experimental | Lactobacillus gasseri DSM 27123 capsules, 1×109 CFU (divided in two doses) |
|
| Placebo | Placebo Comparator | Placebo capsules (two doses) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus gasseri DSM 27123 | Dietary Supplement | 109 CFU (divided in two doses) per day for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of complete spontaneous bowel movements (CSBMs) | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stool Consistency (Bristol Stool Form scale) | Change in Bristol Stool Form Scale | Baseline, week 1, 2, 3 and 4 |
| Change in Patient-Assessment of Constipation Symptoms (PAC-SYM) | Change in score |
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Inclusion Criteria:
The subjects have to meet all of the following criteria to be eligible to enter the study:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Hellström, MD, PhD | Uppsala University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTC, Akademiska Sjukhuset | Uppsala | 751 85 | Sweden |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Dietary Supplement | Two doses per day for 28 days |
|
| Baseline, week 1, 2, 3 and 4 (change from baseline) |
| Change in Gastrointestinal Symptom Rating Scale (GSRS) | Change in Score | Baseline, week 1, 2, 3 and 4 |
| Proportion of responders | Proportion of responders is defined as subjects showing a mean increase of ≥1 CSBM per week during the treatment period (Day 1 to Day 28) compared to the baseline period (Day-14 to Day -1) or ≥3 CSBMs in the last week of the treatment period (Day 21 to Day 28). The subjects will record time and date of all CSBMs in the study diary. | 4 weeks |
| Number of participants with treatement related adverse events | Descriptive | During the whole study - 4 weeks |
| Presence of Lactobacillus gasseri DSM 27123 in faeces | qPCR | 4 weeks |
| Need for laxative medication | Time and date of laxative use will be recorded in the study diary by the subjects. | During the treatment period - 4 weeks |