Probiotics Improve Constipation
ConditionConstipation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWecare Probiotics Co., Ltd.
About this trial
This study is a randomized, double-blind, placebo-controlled trial in which adult subjects with constipation are randomly assigned to either a probiotic group or a placebo group for an 8-week intervention. Through blood and fecal sample analyses combined with multidimensional questionnaire assessments, the study aims to systematically evaluate the efficacy of probiotics in improving gastrointestinal function, immune status, and mental health in patients with constipation.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18 to 65 years (inclusive).
Diagnosed with constipation, defined as fewer than 3 spontaneous bowel movements per week and/or Bristol Stool Form Scale types 1 or 2.
Willing and able to comply with the study protocol and complete all required assessments.
Provide written informed consent prior to any study-related procedures.
Disqualifiers
Use of products with functions similar to the investigational product within a short period prior to screening that may interfere with the evaluation of study outcomes.
Intention to change dietary habits significantly during the study period.
Severe allergies or immunodeficiency.
Women who are pregnant, breastfeeding, or planning to become pregnant during the trial.
Trial design
Design model
Parallel
Treatments tested in this trial
Probitics
Dietary supplementThe intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 1, Week 2, Week 4, and Week 8.
Placebo
Dietary supplementThe intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 1, Week 2, Week 4, and Week 8.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Probiotics GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Improvement of constipation symptoms
Improvement in constipation was assessed using the Bristol Stool Characteristics Scale (BSFS), primarily observing the shift in stool type from type 1-2 (hard stool/constipation) to type 3-4 (normal/ideal soft stool).
Time frame
Baseline, Week 1, Week 2, Week 4, Week 82
Change in Spontaneous Bowel Movement (SBM) Frequency
Change from baseline in number of spontaneous bowel movements. Spontaneous bowel movements are defined as bowel movements occurring without the use of laxatives, enemas, or suppositories within the previous 24 hours.
Time frame
Baseline, Week 1, Week 2, Week 4, Week 8Secondary outcomes
1
Change in Gastrointestinal Symptom Rating Scale (GSRS) Score
Change from baseline in GSRS total and subscale scores. GSRS is a 15-item questionnaire assessing gastrointestinal symptoms across 5 domains (reflux, abdominal pain, indigestion, diarrhea, constipation), each rated on a 7-point Likert scale. Higher scores indicate more severe symptoms.
Time frame
Baseline, Week 1, Week 2, Week 4, Week 82
Change in Patient Assessment of Constipation Symptoms (PAC-SYM) Score
Change from baseline in PAC-SYM total score. PAC-SYM is a 12-item questionnaire assessing constipation-related symptoms across 3 subscales (abdominal, rectal, stool), each rated on a 5-point Likert scale. Higher scores indicate more severe symptoms.
Time frame
Baseline, Week 1, Week 2, Week 4, Week 83
Change in Patient Assessment of Constipation Quality of Life (PAC-QOL) Score
Change from baseline in PAC-QOL total score. PAC-QOL is a 28-item questionnaire assessing quality of life related to constipation across 4 domains (physical discomfort, psychosocial discomfort, worries/concerns, satisfaction), each rated on a 5-point Likert scale. Higher scores indicate poorer quality of life.
Time frame
Baseline, Week 1, Week 2, Week 4, Week 84
Change in Depression, Anxiety, and Stress Scale-21 (DASS-21) Score
Change from baseline in DASS-21 total and subscale scores. DASS-21 is a 21-item questionnaire assessing depression, anxiety, and stress across 3 domains, each rated on a 4-point Likert scale. Higher scores indicate more severe psychological distress.
Time frame
Baseline, Week 1, Week 2, Week 4, Week 8Sponsors and contacts
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Source ClinicalTrials.gov