Lactic Acid Bacteria in Functional Diarrheal Disorders
Efficacy of Lactic Acid Bacteria in Managing Diarrhea-Associated Functional Gastrointestinal Disorders: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether a probiotic supplement can improve symptoms and quality of life in adults with diarrhea-predominant irritable bowel syndrome (IBS-D) or functional diarrhea (FD). These conditions can cause frequent loose stools, abdominal discomfort, and a lower quality of life.
The main questions this study aims to answer are:
- Does the probiotic improve quality of life compared with a placebo (a look-alike capsule that contains no active bacteria)?
- Does the probiotic help participants have more normal stool consistency and fewer bowel movements?
- Is the probiotic safe and well tolerated in people with IBS-D or FD?
Researchers will compare the probiotic supplement with a placebo to see whether the probiotic improves symptoms and quality of life.
Participants will:
- Take either the probiotic or placebo capsule once daily for 3 months.
- Switch to the other study treatment for an additional 3 months.
- Complete quality-of-life questionnaires at the start of the study, after 3 months, and after 6 months.
- Record the number of bowel movements each day throughout the study.
- Record stool consistency each day using the Bristol Stool Form Scale.
- Record daily pain during bowel movements using a Visual Analog Scale (VAS).
- Report any medications they take and any health problems that occur during the study.
The study will follow each participant for 6 months. Researchers hope the results will help determine whether this probiotic is a useful treatment option for people living with IBS-D or functional diarrhea.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Tamás Molnár
- 電話番号：+36-62-545-189
- メール：molnar.tamas@med.u-szeged.hu
研究場所
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Szeged、ハンガリー、6725
- 募集
- University of Szeged
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コンタクト：
- Tamás Molnár
- 電話番号：+36-62-545-189
- メール：molnar.tamas@med.u-szeged.hu
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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:
- Adults aged 18 years or older.
- Have diarrhea-predominant irritable bowel syndrome (IBS-D) or functional diarrhea (FD) diagnosed using Rome V criteria.
- Have had symptoms for at least 6 months.
- Have no warning signs that suggest another digestive disease.
- Have been taking the same treatment for IBS-D, FD, and other medical conditions for at least 1 month before joining the study.
- Are willing and able to provide written informed consent and follow study procedures.
Exclusion Criteria:
- Took antibiotics or probiotic products within the past 4 weeks.
- Had abdominal surgery in the past, except appendix removal (appendectomy).
- Have another type of irritable bowel syndrome or another functional digestive disorder.
- Have a known digestive disease that may explain their symptoms.
- Plan to start a new medication or change the dose of an existing medication during the study (except antispasmodic medications).
- Are unable or unwilling to complete study questionnaires and daily symptom records.
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：クロスオーバー割り当て
- 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：Experimental First Arm
Participants randomized to this arm will receive LL1500, a probiotic supplement containing Lactobacillus rhamnosus and Lactobacillus plantarum, once daily for 3 months, followed by crossover to matching placebo for an additional 3 months under double-blind conditions. |
LL1500 is an oral probiotic supplement administered once daily as a gelatin capsule. Each capsule contains lyophilized Lactobacillus rhamnosus and Lactobacillus plantarum, providing at least 7.5 × 10⁹ colony-forming units (CFU) of each bacterial strain. Participants will receive LL1500 for a 3-month treatment period. Matching oral placebo administered once daily as a gelatin capsule containing inactive excipients and no live bacterial strains. Participants will receive placebo for a 3-month treatment period. |
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プラセボコンパレーター：Placebo First Arm
Participants randomized to this arm will receive matching placebo once daily for 3 months, followed by crossover to LL1500, a probiotic supplement containing Lactobacillus rhamnosus and Lactobacillus plantarum, for an additional 3 months under double-blind conditions. |
LL1500 is an oral probiotic supplement administered once daily as a gelatin capsule. Each capsule contains lyophilized Lactobacillus rhamnosus and Lactobacillus plantarum, providing at least 7.5 × 10⁹ colony-forming units (CFU) of each bacterial strain. Participants will receive LL1500 for a 3-month treatment period. Matching oral placebo administered once daily as a gelatin capsule containing inactive excipients and no live bacterial strains. Participants will receive placebo for a 3-month treatment period. |
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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Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at 3 Months
時間枠：Three months after enrollment
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IBS-specific quality of life assessed using the Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire. The IBS-QOL contains 34 items and yields a total score ranging from 0 to 100, with higher scores indicating better quality of life. The outcome measure is the change in total IBS-QOL score from baseline to 3 months. |
Three months after enrollment
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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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Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at 6 Months
時間枠：Six months after enrollment
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IBS-specific quality of life assessed using the Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire. The IBS-QOL contains 34 items and yields a total score ranging from 0 to 100, with higher scores indicating better quality of life. The outcome measure is the change in total IBS-QOL score from baseline to 6 months. |
Six months after enrollment
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Mean Daily Stool Frequency at 3 Months
時間枠：Three months after enrollment
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Mean number of bowel movements per day recorded by participants. The outcome measure is the change in average daily stool frequency from baseline to 3 months. Lower values indicate fewer bowel movements. |
Three months after enrollment
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Mean Daily Stool Frequency at 6 Months
時間枠：Six months after enrollment
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Mean number of bowel movements per day recorded by participants. The outcome measure is the change in average daily stool frequency from baseline to 6 months. Lower values indicate fewer bowel movements. |
Six months after enrollment
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Mean Bristol Stool Form Scale Score at 3 Months
時間枠：Three months after enrollment
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Stool consistency assessed using the Bristol Stool Form Scale, which ranges from Type 1 (hard stools) to Type 7 (watery stools). Types 3 to 5 are considered normal stool consistency. The outcome measure is the change in mean Bristol Stool Form Scale score from baseline to 3 months. |
Three months after enrollment
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Mean Bristol Stool Form Scale Score at 6 Months
時間枠：Six months after enrollment
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Stool consistency assessed using the Bristol Stool Form Scale, which ranges from Type 1 (hard stools) to Type 7 (watery stools). Types 3 to 5 are considered normal stool consistency. The outcome measure is the change in mean Bristol Stool Form Scale score from baseline to 6 months. |
Six months after enrollment
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Defecation Pain Visual Analog Scale (VAS) Score at 3 Months
時間枠：Three months after enrollment
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Pain during defecation assessed daily using a Visual Analog Scale (VAS). Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The outcome measure is the change in mean daily VAS score from baseline to 3 months. |
Three months after enrollment
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Defecation Pain Visual Analog Scale (VAS) Score at 6 Months
時間枠：Six months after enrollment
|
Pain during defecation assessed daily using a Visual Analog Scale (VAS). Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The outcome measure is the change in mean daily VAS score from baseline to 6 months. |
Six months after enrollment
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Treatment-Emergent Adverse Events
時間枠：From enrollment through 6 months
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Number of participants experiencing any adverse event reported during treatment with either the probiotic supplement or placebo. Adverse events will be collected throughout study participation. |
From enrollment through 6 months
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
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
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