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Lactic Acid Bacteria in Functional Diarrheal Disorders

29 de octubre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Hungría
      • Szeged, Hungría, 6725
        • Reclutamiento
        • University of Szeged
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Suplemento dietético: 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.

Otro: 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.
Comparador de placebos: 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.
Suplemento dietético: 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.

Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at 3 Months
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at 6 Months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Defecation Pain Visual Analog Scale (VAS) Score at 3 Months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Szeged University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de noviembre de 2026

Finalización primaria (Estimado)

1 de noviembre de 2028

Finalización del estudio (Estimado)

1 de noviembre de 2029

Fechas de registro del estudio

Enviado por primera vez

29 de octubre de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de octubre de 2026

Publicado por primera vez (Actual)

4 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NNGYK/09884-2/2026

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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