Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
NCT07923279, Not applicable, Recruiting, Seoul National University Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life | ClinicalTrials.gov |
| NCT number | NCT07923279 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 40 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Seoul National University Hospital | ClinicalTrials.gov |
| Conditions | Constipation, Abdominal Pain, Abdominal Bloating, Abdominal Discomfort | ClinicalTrials.gov |
| Interventions | Lacticaseibacillus rhamnosus BBH112, 1-Kestose (GF2), Dextrin Placebo Powder | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of Participants Satisfied With Overall Gastrointestinal Symptom Improvement | Week 8 | Overall satisfaction with gastrointestinal symptom improvement will be assessed at week 8 using a participant-reported assessment of symptom improvement following supplementation. The outcome will be compared between the group receiving Lacticaseibacillus rhamnosus BBH112 plus 1-kestose and the group receiving BBH112 plus placebo powder. | ClinicalTrials.gov |
| Secondary | Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) | Baseline, Week 4, and Week 8 | Changes in gastrointestinal symptom severity will be assessed using the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS). The total score ranges from 0 to 500, with higher scores indicating greater symptom severity. Changes from baseline to weeks 4 and 8 will be compared between the two treatment groups. | ClinicalTrials.gov |
| Secondary | Change in Irritable Bowel Syndrome Quality of Life (IBS-QoL) Score | Baseline, Week 4, and Week 8 | Changes in disease-related quality of life will be evaluated using the Irritable Bowel Syndrome Quality of Life (IBS-QoL) questionnaire. The transformed total score ranges from 0 to 100, with higher scores indicating better quality of life. Changes from baseline to weeks 4 and 8 will be compared between the two treatment groups. | ClinicalTrials.gov |
| Secondary | Change in Gastrointestinal Symptom Severity Scores | Baseline, Week 4, and Week 8 | Changes in individual gastrointestinal symptoms, including abdominal pain, abdominal discomfort, bloating, constipation, and diarrhea-related symptoms, will be evaluated using symptom-based questionnaires derived from the Rome IV assessment. Symptom severity will be rated on a scale from 0 to 10, with higher scores indicating more severe symptoms. Changes from baseline to weeks 4 and 8 will be compared between groups. | ClinicalTrials.gov |
| Secondary | Change in Stool Consistency Assessed by the Bristol Stool Form Scale (BSFS) | Baseline, Week 4, and Week 8 | Changes in stool consistency will be assessed using the Bristol Stool Form Scale (BSFS), which classifies stool form into seven types (1-7), ranging from separate hard lumps to entirely liquid stools. Changes in mean BSFS scores from baseline to weeks 4 and 8 will be compared between the two treatment groups. | ClinicalTrials.gov |
| Secondary | Change in Hospital Anxiety and Depression Scale (HADS) Scores | Baseline, Week 4, and Week 8 | Changes in anxiety and depressive symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS). The questionnaire consists of two subscales, HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D), each ranging from 0 to 21, with higher scores indicating more severe symptoms. Changes in subscale scores from baseline to weeks 4 and 8 will be compared between groups. | ClinicalTrials.gov |
| Secondary | Change in Gut Microbiome Diversity and Composition | Baseline and Week 8 | Changes in fecal gut microbiome diversity and composition will be evaluated using 16S rRNA gene sequencing of stool samples collected at baseline and week 8. Alpha diversity will be assessed using the Shannon diversity index and observed features, while beta diversity will be evaluated using Bray-Curtis dissimilarity and weighted and unweighted UniFrac distances. Changes in microbial diversity and composition will be compared between the two treatment groups. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)