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Lactic Acid Bacteria in Functional Diarrheal Disorders

29 ottobre 2026 aggiornato da: Szeged University

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Integratore alimentare: LL1500

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.

Altro: Placebo Capsule

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.
Comparatore placebo: 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.
Integratore alimentare: LL1500

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.

Altro: Placebo Capsule

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at 3 Months
Lasso di tempo: Three 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 3 months.
Three months after enrollment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at 6 Months
Lasso di tempo: 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
Mean Daily Stool Frequency at 3 Months
Lasso di tempo: Three months after enrollment

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
Mean Daily Stool Frequency at 6 Months
Lasso di tempo: Six months after enrollment

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
Mean Bristol Stool Form Scale Score at 3 Months
Lasso di tempo: Three 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 3 months.
Three months after enrollment
Mean Bristol Stool Form Scale Score at 6 Months
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Defecation Pain Visual Analog Scale (VAS) Score at 3 Months
Lasso di tempo: Three 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 3 months.
Three months after enrollment
Defecation Pain Visual Analog Scale (VAS) Score at 6 Months
Lasso di tempo: 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
Treatment-Emergent Adverse Events
Lasso di tempo: From enrollment through 6 months

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Szeged University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 novembre 2028

Completamento dello studio (Stimato)

1 novembre 2029

Date di iscrizione allo studio

Primo inviato

29 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 ottobre 2026

Primo Inserito (Effettivo)

4 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NNGYK/09884-2/2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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