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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Tamás Molnár
- Telefonní číslo: +36-62-545-189
- E-mail: molnar.tamas@med.u-szeged.hu
Studijní místa
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Szeged, Maďarsko, 6725
- Nábor
- University of Szeged
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Kontakt:
- Tamás Molnár
- Telefonní číslo: +36-62-545-189
- E-mail: molnar.tamas@med.u-szeged.hu
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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. |
|
Komparátor placeba: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at 3 Months
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at 6 Months
Časové okno: Six months after enrollment
|
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Six months after enrollment
|
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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Defecation Pain Visual Analog Scale (VAS) Score at 3 Months
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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