Exploring the Potential Benefits of Probiotic Yogurt
ConditionChronic Constipation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWecare Probiotics Co., Ltd.
About this trial
This study aims to evaluate the effect of a high-activity probiotic yogurt on improving symptoms of chronic constipation, observing its regulatory effects on the gut microbiota and the incidence of adverse reactions in study participants over a 21-day intervention period.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Meet the Rome IV diagnosis criteria for chronic constipation;
Patients who are able to understand clinical studies and are committed to complying with study requirements and procedures;
Age 18-65. -
Disqualifiers
Systemic (diabetes, autoimmune diseases, cancer), gastrointestinal or liver diseases known to be associated with alterations in the gut microbiota;
Patients who are pregnant or lactating;
have taken antimicrobials, probiotics, or drugs that inhibit stomach acid or gastrointestinal motility in the past 6 weeks;
Patients who changed their diet type during the study;
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotic yogurt group
Dietary supplementThe intervention phase of this study will last 3 weeks, and each participant will make 3 visits (week 0, week 1, week 3).
Yogurt control group
Dietary supplementThe intervention phase of this study will last 3 weeks, and each participant will make 3 visits (week 0, week 1, week 3).
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Probiotic groupActive comparator 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Constipation symptom improvement
The Bristol Stool Form Scale (BSFS) will be used to assess improvements in constipation. The BSFS is a 9-point scale ranging from 1 to 7, where higher scores indicate softer stool consistency, approaching a liquid state. The specific scoring is as follows: 1. Separate hard lumps, like nuts (difficult to pass) 2. Sausage-shaped but lumpy 3. Like a sausage but with cracks on the surface 4. Like a sausage or snake, smooth and soft 5. Soft blobs with clear-cut edges (passed easily) 6. Fluffy pieces with ragged edges, a mushy stool 7. Watery, no solid pieces, entirely liquid Scores of 4, 5, and 6 are generally considered ideal, indicating smooth bowel movements without constipation. Therefore, higher scores (closer to 4-6) represent improved constipation symptoms, while lower scores (1-3) indicate more severe constipation.
Time frame
3 weeksSecondary outcomes
1
Gut microbiota composition and diversity
Evaluating the changes in the composition and diversity of the gut microbiota before and after the intake of probiotic yogurt using high-throughput sequencing technology.
Time frame
3 weeks2
Emotional state changes
Hospital Anxiety and Depression Scale (HADS) The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in participants' emotional state during the study period. The HADS consists of two subscales: one for anxiety (HADS-A) and one for depression (HADS-D), each containing 7 items. Scoring Range: Each subscale is scored from 0 to 21. Interpretation: Higher scores indicate greater levels of anxiety or depression.
Time frame
3 weeks3
Emotional state changes
Depression Anxiety Stress Scales (DASS) The Depression Anxiety Stress Scales (DASS) will be used to assess changes in participants' emotional state during the study period. The DASS includes three subscales: Depression (DASS-D), Anxiety (DASS-A), and Stress (DASS-S), each containing 14 items. Scoring Range: Each subscale is scored from 0 to 42. Interpretation: Higher scores indicate greater levels of depression, anxiety, or stress.
Time frame
3 weeks4
Weight management impact
Assessing the impact of probiotic yogurt intake on participants' weight management by measuring body weight.
Time frame
3 weeksSponsors and contacts
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Source ClinicalTrials.gov