An interventional study of Lacticaseibacillus rhamnosus BBH112 and 1-Kestose (GF2) in Constipation, Abdominal Pain and Abdominal Bloating, sponsored by Seoul National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.
This study's planned enrollment of 40 is below the median of 75 across 884 interventional studies indexed under Constipation.
Browse Constipation studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
**Inclusion Criteria:**
**Exclusion Criteria:**
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Lacticaseibacillus rhamnosus BBH112 · Dietary Supplement: 1-Kestose (GF2)
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.
Dietary Supplement: Lacticaseibacillus rhamnosus BBH112 · Dietary Supplement: Dextrin Placebo Powder
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) 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.
Also known as: Kestose
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.
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.
Time frame: Week 8
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 8
Plan to share: No
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