Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
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.
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Gyeonggi-do
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Seongnam-si、Gyeonggi-do、韓国、13620
- 募集
- Seoul National University Bundang Hospital
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コンタクト：
- Ho-Kyoung Lee
- 電話番号：+82-10-3552-3177
- メール：hokyung0327@naver.com
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コンタクト：
- Cheol Min Shin
- 電話番号：+82-31-787-7009
- メール：scm6md@gmail.com
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主任研究者：
- Cheol Min Shin
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
**Inclusion Criteria:**
- 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.
**Exclusion Criteria:**
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Pregnant or breastfeeding women.
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Individuals whose predominant gastrointestinal symptom is diarrhea.
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Participation in another investigational drug trial within 3 months before Visit 1. Individual cases may be reviewed in consultation with the study monitor.
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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.
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Severe congestive heart failure or severe angina pectoris.
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Diagnosed lactose intolerance or immunosuppression.
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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.
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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.
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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.
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Impaired renal function, defined as serum creatinine greater than 2.0 mg/dL at Visit 1, or the presence of nephrotic syndrome.
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Diagnosis of malignancy within the previous 5 years, except for individuals considered cured.
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Significant psychiatric instability or psychiatric disorders that are not adequately controlled with medication or psychiatric treatment.
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Use of systemic corticosteroids within 1 month before Visit 1.
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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.
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Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Probiotic (L.rhamnosus BBH112) Plus Prebiotic (1-Kestose)
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. |
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.
他の名前：
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アクティブコンパレータ：Probiotic (L.rhamnosus BBH112) Plus Placebo
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. |
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. 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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Participants Satisfied With Overall Gastrointestinal Symptom Improvement
時間枠：Week 8
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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. |
Week 8
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
時間枠：Baseline, Week 4, and Week 8
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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. |
Baseline, Week 4, and Week 8
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Change in Irritable Bowel Syndrome Quality of Life (IBS-QoL) Score
時間枠：Baseline, Week 4, and Week 8
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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. |
Baseline, Week 4, and Week 8
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Change in Gastrointestinal Symptom Severity Scores
時間枠：Baseline, Week 4, and Week 8
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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. |
Baseline, Week 4, and Week 8
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Change in Stool Consistency Assessed by the Bristol Stool Form Scale (BSFS)
時間枠：Baseline, Week 4, and Week 8
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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. |
Baseline, Week 4, and Week 8
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Change in Hospital Anxiety and Depression Scale (HADS) Scores
時間枠：Baseline, Week 4, and Week 8
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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. |
Baseline, Week 4, and Week 8
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Change in Gut Microbiome Diversity and Composition
時間枠：Baseline and Week 8
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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. |
Baseline and Week 8
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- B-2604-1036-002
- 2024ER211402 (その他の助成金/資金番号：National Institute of Health, Korea)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
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