Probiotics Alleviate Functional Constipation in Adults | NCT06879587

NCT06879587

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic Group	Experimental	Participants receive one sachet per day containing probiotic BC99 and maltodextrin (Week 0 to Week8).	Dietary Supplement: Probiotic
Placebo Group	Placebo Comparator	Participants receive one sachet per day containing maltodextrin only, serving as the placebo(Week 0 to Week8).	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic	Dietary Supplement	During the intervention, participants could take BC99 daily and record any adverse reactions. Participants filled out questionnaires and collected stool and serum samples, which were used to detect and analyze the improvement of participants' constipation function.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in colonic transit time (CTT) from baseline to 8 weeks	Colonic transit time (hours) was measured by radiolabmarking, and the reduction from baseline was an indicator of effectiveness.	Week 0 and Week 8
Change in Patient Assessment of Constipation Symptoms (PAC-SYM) score from baseline to 8 weeks.	The PAC-SYM questionnaire was used to assess the severity of constipation symptoms (12 items, 0-4 Likert score), with a total score ranging from 0-48 (the lower the score, the milder the symptoms). The magnitude of the decline from the baseline score is an indicator of effectiveness.	Week 0 and Week 8

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chinese adults aged 18-70 who meet the following Rome-IV diagnostic criteria for Functional constipation:

i. If the following symptoms started at least 6 months ago and have been present for the past 3 months with two or more of the following:
1. Straining during more than 25% of defecations
2. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than 25% of defecations
3. Sensation of incomplete evacuation more than 25% of defecations
4. Sensation of anorectal obstruction/blockage more than 25% of defecations
5. Manual maneuvers to facilitate more than 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
6. Fewer than three SBM per week ii Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome.
Able to complete the study according to the requirements of the trial protocol;
Patients who have signed the informed consent form;
Research participants (including male participants) who have no fertility plans from 14 days before screening until 6 months after the end of the trial and are willing to take effective contraceptive measures.

Only those who meet all the above conditions can be selected for the study. -

Exclusion Criteria:

The use of probiotics, prebiotics, or antibiotics within 2 weeks of enrollment.
Regular use of a high-fiber diet, as measured by the recommended food score (RFS);
Regular use of medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea.
Currently have, or have had in the past 2 years, any gastrointestinal conditions such as: Crohn's disease, celiac disease, Ulcerative colitis, Malignant tumor of the colon.
Medical history of cardiovascular, liver, or renal diseases; alcoholics.
Hypersensitivity to probiotics or the ingredients used in this study.
Pregnancy or breastfeeding.
Participation in another clinical trial in the 3 months before enrollment. All participants provided written informed consent. -

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms