ConstipationNCT07923279
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
A study testing Lacticaseibacillus rhamnosus BBH112 and 1-Kestose (GF2) in people with Constipation and Abdominal Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to evaluate whether a combination of a prebiotic (1-kestose) and a probiotic (Lacticaseibacillus rhamnosus BBH112) improves gastrointestinal symptoms and quality of life in adults with constipation-related symptoms. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Constipation, Abdominal Pain, Abdominal Bloating
- What is being tested?
- Lacticaseibacillus rhamnosus BBH112 and 1-Kestose (GF2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jul 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Korean men and women aged 19 to 80 years.
- Adults experiencing constipation-related lower gastrointestinal symptoms, including abdominal pain or bloating, along with constipation symptoms such as excessive straining during defecation, hard stools (Bristol Stool Form Scale types 1-2), or fewer than three bowel movements per week.
- No diagnosed organic gastrointestinal disease.
- Colonoscopy performed within the previous 5 years, or at enrollment, confirming the absence of significant organic colonic disease. Colonoscopy reports from other institutions are acceptable. Individuals who underwent biopsy or polypectomy may be enrolled if the investigator determines that participation is appropriate after reviewing the results.
- Women who are surgically sterile or women of childbearing potential with a negative urine or serum pregnancy test who agree to use appropriate contraception during the study. Appropriate contraceptive methods include oral contraceptives, intrauterine devices, double-barrier methods, or hormonal implants. Male participants must also agree to appropriate contraceptive measures during the study.
- Individuals capable of understanding the study and communicating their decisions clearly, without significant uncontrolled neurological or psychiatric conditions. Individuals with adequately controlled neurological or psychiatric disorders may participate.
- Individuals who voluntarily provide written informed consent to participate in the study.
Who cannot join
- Pregnant or breastfeeding women.
- Individuals whose predominant gastrointestinal symptom is diarrhea.
- Participation in another investigational drug trial within 3 months before Visit 1. Individual cases may be reviewed in consultation with the study monitor.
- Any condition or circumstance that, in the investigator's judgment, may increase the risks associated with study participation or interfere with the conduct of the study.
- Severe congestive heart failure or severe angina pectoris.
- Diagnosed lactose intolerance or immunosuppression.
Show all 18Show fewer
- Current use of medications that may affect the study intervention or outcomes, including gastrointestinal medications, probiotics, intestinal regulators, or antibiotics, unless the following conditions are met:
- Probiotic use may be discontinued at least 2 weeks before enrollment.
- Antibiotics or gastrointestinal medications, including potassium-competitive acid blockers, proton pump inhibitors, histamine-2 receptor antagonists, pinaverium, or trimebutine, may be discontinued at least 4 weeks before enrollment.
- Participants requiring continued gastrointestinal medications may be eligible if the type and dosage of these medications remain unchanged throughout the study period.
- Uncontrolled hypertension, defined as systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg at Visit 1, regardless of antihypertensive treatment.
- Uncontrolled endocrine disorders (including diabetes mellitus), metabolic disorders (such as secondary hyperlipidemia), or hypothyroidism. Participants with a history of hypothyroidism may be eligible if they have received stable thyroid hormone replacement therapy for at least 4 weeks before the study visit and have a thyroid-stimulating hormone (TSH) level within the normal reference range at Visit 2.
- Impaired renal function, defined as serum creatinine greater than 2.0 mg/dL at Visit 1, or the presence of nephrotic syndrome.
- Diagnosis of malignancy within the previous 5 years, except for individuals considered cured.
- Significant psychiatric instability or psychiatric disorders that are not adequately controlled with medication or psychiatric treatment.
- Use of systemic corticosteroids within 1 month before Visit 1.
- History of abdominal surgery other than appendectomy, cesarean section, hysterectomy, or hernia surgery. Individuals with other abdominal surgical histories may be enrolled if the investigator determines that participation is appropriate.
- Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Ho-Kyoung Lee, +82-10-3552-3177, hokyung0327@naver.com
Cheol Min Shin, +82-31-787-7009, scm6md@gmail.com
About this study
Official title: Effects of a Prebiotic-Probiotic Combination on Gastrointestinal Symptoms and Quality of Life in Individuals With Constipation: A Randomized, Double-Blind, Controlled Trial
This study aims to evaluate whether a combination of a prebiotic (1-kestose) and a probiotic (Lacticaseibacillus rhamnosus BBH112) improves gastrointestinal symptoms and quality of life in adults with constipation-related symptoms.
A total of 40 adults aged 19 to 80 years will be enrolled in this randomized, double-blind, controlled trial. Participants will be randomly assigned to receive either the probiotic combined with the prebiotic or the probiotic combined with a placebo for 8 weeks.
Read more
The primary objective is to compare overall satisfaction with gastrointestinal symptom improvement between the two groups after 8 weeks. The study will also assess changes in abdominal pain, bloating, bowel habits, stool consistency, quality of life, and psychological well-being. In addition, changes in the gut microbiome will be evaluated using stool samples collected before and after the intervention.
The findings may help determine whether adding a prebiotic to probiotic supplementation provides additional benefits for adults experiencing constipation-related gastrointestinal symptoms.
Read the detailed description
Constipation and related gastrointestinal symptoms, including abdominal pain, bloating, and abdominal discomfort, are common complaints that can substantially impair quality of life. Alterations in the gut microbiome have been suggested to contribute to gastrointestinal symptoms through their effects on intestinal motility, visceral sensitivity, and gut-brain interactions. Probiotics and prebiotics have been investigated as potential interventions for improving gastrointestinal symptoms by modulating the gut microbiome.
Lacticaseibacillus rhamnosus BBH112 is a probiotic strain isolated from a healthy human donor. 1-Kestose (GF2) is a prebiotic fructooligosaccharide that may promote the growth and activity of beneficial intestinal bacteria. The combination of these two components may provide additional benefits compared with probiotic supplementation alone.
This prospective, randomized, double-blind, controlled trial aims to evaluate the efficacy and safety of combined prebiotic and probiotic supplementation in adults with constipation-related gastrointestinal symptoms.
A total of 40 participants aged 19 to 80 years will be enrolled at Seoul National University Bundang Hospital, Republic of Korea. Eligible participants will be randomly assigned in a 1:1 ratio to one of two groups:
Experimental group: Lacticaseibacillus rhamnosus BBH112 (two capsules once daily) combined with 1-kestose (5 g twice daily).
Control group: Lacticaseibacillus rhamnosus BBH112 (two capsules once daily) combined with placebo powder (5 g twice daily).
Both groups will receive the assigned supplementation for 8 weeks. Participants and investigators will remain blinded to group allocation.
The primary outcome is the between-group difference in overall satisfaction with gastrointestinal symptom improvement at week 8.
Secondary outcomes include changes in gastrointestinal symptom severity, assessed using the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) and symptom-based questionnaires; quality of life, assessed using the IBS Quality of Life questionnaire (IBS-QoL); bowel movement frequency and stool consistency, assessed using bowel habit questionnaires and the Bristol Stool Form Scale (BSFS); and psychological well-being, assessed using the Hospital Anxiety and Depression Scale (HADS). Clinical outcomes will be evaluated at baseline, week 4, and week 8.
Stool samples will be collected at baseline and week 8 to evaluate changes in gut microbiome composition and diversity. The study will also explore associations between microbiome changes and improvements in gastrointestinal symptoms.
Safety will be assessed through monitoring of adverse events during the study period.
This study is expected to provide preliminary clinical evidence regarding the potential additional benefits of combining a prebiotic with probiotic supplementation for constipation-related gastrointestinal symptoms and associated changes in the gut microbiome.
- Conditions
- Constipation, Abdominal Pain, Abdominal Bloating, Abdominal Discomfort
- Being tested
- Lacticaseibacillus rhamnosus BBH112, 1-Kestose (GF2), Dextrin Placebo Powder
- Keywords
- Probiotics, Prebiotics, 1-Kestose, Lacticaseibacillus rhamnosus BBH112, Constipation-related Gastrointestinal Symptoms, Lower Gastrointestinal Symptoms
- Medical subject headings
- Constipation, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacticaseibacillus rhamnosus BBH112Dietary supplement
Lacticaseibacillus rhamnosus BBH112 is a probiotic strain isolated from a healthy human donor. The probiotic is administered orally as two capsules once daily for 8 weeks. Each capsule contains 1 × 10^10 colony-forming units (CFU) of L. rhamnosus BBH112, providing a total daily dose of 2 × 10^10 CFU. Participants in both the experimental and active comparator groups will receive this probiotic supplementation.
1-Kestose (GF2)Dietary supplement
Also called Kestose
1-Kestose (GF2) is a prebiotic fructooligosaccharide with a purity of at least 98%. Participants assigned to the experimental group will receive 1-kestose powder orally at a dose of 5 g twice daily (total daily dose of 10 g) for 8 weeks, in combination with Lacticaseibacillus rhamnosus BBH112. The intervention aims to evaluate the additional effects of prebiotic supplementation on constipation-related gastrointestinal symptoms, bowel habits, quality of life, and gut microbiome composition.
Dextrin Placebo PowderDietary supplement
Participants assigned to the active comparator group will receive placebo powder orally at a dose of 5 g twice daily (total daily dose of 10 g) for 8 weeks, in combination with Lacticaseibacillus rhamnosus BBH112. The placebo will be administered under blinded conditions to allow comparison with the prebiotic intervention.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic (L.rhamnosus BBH112) Plus Prebiotic (1-Kestose) | Experimental | Participants in the experimental group will receive Lacticaseibacillus rhamnosus BBH112 (two capsules orally once daily) in combination with the prebiotic 1-kestose (GF2, 5 g orally twice daily) for 8 weeks. This group will be evaluated to determine whether the addition of 1-kestose to probiotic supplementation improves constipation-related gastrointestinal symptoms, bowel habits, and quality of life. Receives: Dietary Supplement: Lacticaseibacillus rhamnosus BBH112; Dietary Supplement: 1-Kestose (GF2) |
| Probiotic (L.rhamnosus BBH112) Plus Placebo | Active comparator | Participants in the active comparator group will receive Lacticaseibacillus rhamnosus BBH112 (two capsules orally once daily) in combination with placebo powder (dextrin, 5 g orally twice daily) for 8 weeks. This group will serve as the comparator to assess the additional effects of 1-kestose supplementation beyond probiotic administration alone on constipation-related gastrointestinal symptoms, bowel habits, and quality of life. Receives: Dietary Supplement: Lacticaseibacillus rhamnosus BBH112; Dietary Supplement: Dextrin Placebo Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Satisfied With Overall Gastrointestinal Symptom Improvement
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.
Measured: Week 8
Secondary outcomes (6)
Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
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.
Measured: Baseline, Week 4, and Week 8
Change in Irritable Bowel Syndrome Quality of Life (IBS-QoL) Score
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.
Measured: Baseline, Week 4, and Week 8
Change in Gastrointestinal Symptom Severity Scores
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.
Measured: Baseline, Week 4, and Week 8
Change in Stool Consistency Assessed by the Bristol Stool Form Scale (BSFS)
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.
Measured: Baseline, Week 4, and Week 8
Change in Hospital Anxiety and Depression Scale (HADS) Scores
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.
Measured: Baseline, Week 4, and Week 8
Change in Gut Microbiome Diversity and Composition
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.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start10 Jul 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective, randomized, double-blind, parallel-group controlled trial. A total of 40 participants with constipation-related gastrointestinal symptoms will be randomly assigned in a 1:1 ratio to receive either Lacticaseibacillus rhamnosus BBH112 combined with 1-kestose (experimental group, n=20) or Lacticaseibacillus rhamnosus BBH112 combined with placebo powder (active comparator group, n=20). Both groups will receive the assigned intervention for 8 weeks. Clinical outcomes will be assessed at baseline, week 4, and week 8.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health, Korea
- Responsible party
- Principal investigator, Cheol Min Shin, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923279
- Sponsor's protocol ID
- B-2604-1036-002
- Other IDs
- 2024ER211402
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Prebiotic-Probiotic Combination on Gastrointestinal Symptoms and Quality of Life in Individuals With Constipation: A Randomized, Double-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT07923279
- Acronym / sponsor ID
- B-2604-1036-002
- Conditions
- Constipation, Abdominal Pain, Abdominal Bloating, Abdominal Discomfort
- Keywords
- Probiotics, Prebiotics, 1-Kestose, Lacticaseibacillus rhamnosus BBH112, Constipation-related Gastrointestinal Symptoms, Lower Gastrointestinal Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Institute of Health, Korea
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate whether a combination of a prebiotic (1-kestose) and a probiotic (Lacticaseibacillus rhamnosus BBH112) improves gastrointestinal symptoms and quality of life in adults with constipation-related symptoms.
A total of 40 adults aged 19 to 80 years will be enrolled in this randomized, double-blind, controlled trial. Participants will be randomly assigned to receive either the probiotic combined with the prebiotic or the probiotic combined with a placebo for 8 weeks.
The primary objective is to compare overall satisfaction with gastrointestinal symptom improvement between the two groups after 8 weeks. The study will also assess changes in abdominal pain, bloating, bowel habits, stool consistency, quality of life, and psychological well-being. In addition, changes in the gut microbiome will be evaluated using stool samples collected before and after the intervention.
The findings may help determine whether adding a prebiotic to probiotic supplementation provides additional benefits for adults experiencing constipation-related gastrointestinal symptoms.
Detailed description
Constipation and related gastrointestinal symptoms, including abdominal pain, bloating, and abdominal discomfort, are common complaints that can substantially impair quality of life. Alterations in the gut microbiome have been suggested to contribute to gastrointestinal symptoms through their effects on intestinal motility, visceral sensitivity, and gut-brain interactions. Probiotics and prebiotics have been investigated as potential interventions for improving gastrointestinal symptoms by modulating the gut microbiome.
Lacticaseibacillus rhamnosus BBH112 is a probiotic strain isolated from a healthy human donor. 1-Kestose (GF2) is a prebiotic fructooligosaccharide that may promote the growth and activity of beneficial intestinal bacteria. The combination of these two components may provide additional benefits compared with probiotic supplementation alone.
This prospective, randomized, double-blind, controlled trial aims to evaluate the efficacy and safety of combined prebiotic and probiotic supplementation in adults with constipation-related gastrointestinal symptoms.
A total of 40 participants aged 19 to 80 years will be enrolled at Seoul National University Bundang Hospital, Republic of Korea. Eligible participants will be randomly assigned in a 1:1 ratio to one of two groups:
Experimental group: Lacticaseibacillus rhamnosus BBH112 (two capsules once daily) combined with 1-kestose (5 g twice daily).
Control group: Lacticaseibacillus rhamnosus BBH112 (two capsules once daily) combined with placebo powder (5 g twice daily).
Both groups will receive the assigned supplementation for 8 weeks. Participants and investigators will remain blinded to group allocation.
The primary outcome is the between-group difference in overall satisfaction with gastrointestinal symptom improvement at week 8.
Secondary outcomes include changes in gastrointestinal symptom severity, assessed using the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) and symptom-based questionnaires; quality of life, assessed using the IBS Quality of Life questionnaire (IBS-QoL); bowel movement frequency and stool consistency, assessed using bowel habit questionnaires and the Bristol Stool Form Scale (BSFS); and psychological well-being, assessed using the Hospital Anxiety and Depression Scale (HADS). Clinical outcomes will be evaluated at baseline, week 4, and week 8.
Stool samples will be collected at baseline and week 8 to evaluate changes in gut microbiome composition and diversity. The study will also explore associations between microbiome changes and improvements in gastrointestinal symptoms.
Safety will be assessed through monitoring of adverse events during the study period.
This study is expected to provide preliminary clinical evidence regarding the potential additional benefits of combining a prebiotic with probiotic supplementation for constipation-related gastrointestinal symptoms and associated changes in the gut microbiome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study is a prospective, randomized, double-blind, parallel-group controlled trial. A total of 40 participants with constipation-related gastrointestinal symptoms will be randomly assigned in a 1:1 ratio to receive either Lacticaseibacillus rhamnosus BBH112 combined with 1-kestose (experimental group, n=20) or Lacticaseibacillus rhamnosus BBH112 combined with placebo powder (active comparator group, n=20). Both groups will receive the assigned intervention for 8 weeks. Clinical outcomes will be assessed at baseline, week 4, and week 8.
| Arm | Type | Receives |
|---|---|---|
| Probiotic (L.rhamnosus BBH112) Plus Prebiotic (1-Kestose) | Experimental | Dietary Supplement: Lacticaseibacillus rhamnosus BBH112, Dietary Supplement: 1-Kestose (GF2)Participants in the experimental group will receive Lacticaseibacillus rhamnosus BBH112 (two capsules orally once daily) in combination with the prebiotic 1-kestose (GF2, 5 g orally twice daily) for 8 weeks. This group will be evaluated to determine whether the addition of 1-kestose to probiotic supplementation improves constipation-related gastrointestinal symptoms, bowel habits, and quality of life. |
| Probiotic (L.rhamnosus BBH112) Plus Placebo | Active comparator | Dietary Supplement: Lacticaseibacillus rhamnosus BBH112, Dietary Supplement: Dextrin Placebo PowderParticipants in the active comparator group will receive Lacticaseibacillus rhamnosus BBH112 (two capsules orally once daily) in combination with placebo powder (dextrin, 5 g orally twice daily) for 8 weeks. This group will serve as the comparator to assess the additional effects of 1-kestose supplementation beyond probiotic administration alone on constipation-related gastrointestinal symptoms, bowel habits, and quality of life. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Korean men and women aged 19 to 80 years.
- Adults experiencing constipation-related lower gastrointestinal symptoms, including abdominal pain or bloating, along with constipation symptoms such as excessive straining during defecation, hard stools (Bristol Stool Form Scale types 1-2), or fewer than three bowel movements per week.
- No diagnosed organic gastrointestinal disease.
- Colonoscopy performed within the previous 5 years, or at enrollment, confirming the absence of significant organic colonic disease. Colonoscopy reports from other institutions are acceptable. Individuals who underwent biopsy or polypectomy may be enrolled if the investigator determines that participation is appropriate after reviewing the results.
- Women who are surgically sterile or women of childbearing potential with a negative urine or serum pregnancy test who agree to use appropriate contraception during the study. Appropriate contraceptive methods include oral contraceptives, intrauterine devices, double-barrier methods, or hormonal implants. Male participants must also agree to appropriate contraceptive measures during the study.
Key exclusion criteria (18 listed)
- Pregnant or breastfeeding women.
- Individuals whose predominant gastrointestinal symptom is diarrhea.
- Participation in another investigational drug trial within 3 months before Visit 1. Individual cases may be reviewed in consultation with the study monitor.
- Any condition or circumstance that, in the investigator's judgment, may increase the risks associated with study participation or interfere with the conduct of the study.
- Severe congestive heart failure or severe angina pectoris.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lacticaseibacillus rhamnosus BBH112Lacticaseibacillus rhamnosus BBH112 is a probiotic strain isolated from a healthy human donor. The probiotic is administered orally as two capsules once daily for 8 weeks. Each capsule contains 1 × 10^10 colony-forming units (CFU) of L. rhamnosus BBH112, providing a total daily dose of 2 × 10^10 CFU. Participants in both the experimental and active comparator groups will receive this probiotic supplementation. | Dietary supplement | Probiotic (L.rhamnosus BBH112) Plus Placebo, Probiotic (L.rhamnosus BBH112) Plus Prebiotic (1-Kestose) |
| 1-Kestose (GF2)Also: Kestose1-Kestose (GF2) is a prebiotic fructooligosaccharide with a purity of at least 98%. Participants assigned to the experimental group will receive 1-kestose powder orally at a dose of 5 g twice daily (total daily dose of 10 g) for 8 weeks, in combination with Lacticaseibacillus rhamnosus BBH112. The intervention aims to evaluate the additional effects of prebiotic supplementation on constipation-related gastrointestinal symptoms, bowel habits, quality of life, and gut microbiome composition. | Dietary supplement | Probiotic (L.rhamnosus BBH112) Plus Prebiotic (1-Kestose) |
| Dextrin Placebo PowderParticipants assigned to the active comparator group will receive placebo powder orally at a dose of 5 g twice daily (total daily dose of 10 g) for 8 weeks, in combination with Lacticaseibacillus rhamnosus BBH112. The placebo will be administered under blinded conditions to allow comparison with the prebiotic intervention. | Dietary supplement | Probiotic (L.rhamnosus BBH112) Plus Placebo |
Primary outcome
Proportion of Participants Satisfied With Overall Gastrointestinal Symptom Improvement
Time frame: 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.
6 secondary outcomes
Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
Time frame: Baseline, Week 4, and Week 8
Change in Irritable Bowel Syndrome Quality of Life (IBS-QoL) Score
Time frame: Baseline, Week 4, and Week 8
Change in Gastrointestinal Symptom Severity Scores
Time frame: Baseline, Week 4, and Week 8
Change in Stool Consistency Assessed by the Bristol Stool Form Scale (BSFS)
Time frame: Baseline, Week 4, and Week 8
Change in Hospital Anxiety and Depression Scale (HADS) Scores
Time frame: Baseline, Week 4, and Week 8
Change in Gut Microbiome Diversity and Composition
Time frame: Baseline and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seoul National University Bundang Hospital
Seongnam-si, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lacticaseibacillus rhamnosus BBH112 and 1-Kestose (GF2) in people with Constipation and Abdominal Pain, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Satisfied With Overall Gastrointestinal Symptom Improvement (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.