An interventional study of Vaginal Probiotic in Irritable Bowel Syndrome and Vaginal Health, sponsored by Rael. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by Rael · Not applicable, Interventional, and Other
This is a virtual single-group study that will last 12 weeks. Participants will take 1 capsule every day, with water. Questionnaires will be completed at baseline, 2 weeks, 4 weeks, and 12 weeks.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 40 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Rael is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Self-reported issues associated with bacterial Vaginosis, reporting three of the following symptoms:
Self-reported symptoms associated with irritable bowel syndrome (IBS), including three of the following symptoms:
Exclusion Criteria:
Participants will take one capsule of the test product every day, with water.
Dietary Supplement: Vaginal Probiotic
This product contains: Probiotic Blend - 5 Strains Lactobacillus acidophilus Lactobacillus rhamnosus Lactobacillus gasseri Lactobacillus acidophilus (NCFM) Lactobacillus casei
Changes in symptoms of bacterial vaginosis.
Participants will complete self-reported questionnaires reporting on incidence and severity of symptoms of bacterial vaginosis.
Time frame: Baseline to Week 12
Changes in vaginal odor.
Participants will complete self-reported questionnaires reporting their perceptions of their vaginal odor. Responses will be gathered on a 5-point Likert scale, with 0= the most favorable severe and 5= the least favorable response.
Time frame: Baseline to Week 12
Changes in vaginal itchiness.
Participants will complete self-reported questionnaires reporting the severity of vaginal itching. Responses will be gathered on a 5-point Likert scale, with 0= the least severe and 5= most severe response.
Time frame: Baseline to Week 12
Changes in vaginal discharge.
Participants will complete self-reported questionnaires reporting their perceptions of their vaginal discharge. Responses will be gathered on a 5-point Likert scale, with 0= the most favorable severe and 5= the least favorable response.
Time frame: Baseline to Week 12
Changes in vaginal dryness.
Participants will complete self-reported questionnaires reporting the severity of vaginal dryness. Responses will be gathered on a 5-point Likert scale, with 0= the least severe and 5= most severe response.
Time frame: Baseline to Week 12
Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS).
The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Time frame: Baseline to Week 12
Changes in scores on the Bristol Stool Chart.
On the Bristol Stool Chart, stools are assigned a number from 1 to 7, from hardest to loosest. Normal stools are those in the middle of the chart, in the 3 to 4 range
Time frame: Baseline to Week 12
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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