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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Tamás Molnár
- Telefonnummer: +36-62-545-189
- E-post: molnar.tamas@med.u-szeged.hu
Studiesteder
-
-
-
Szeged, Ungarn, 6725
- Rekruttering
- University of Szeged
-
Ta kontakt med:
- Tamás Molnár
- Telefonnummer: +36-62-545-189
- E-post: molnar.tamas@med.u-szeged.hu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Placebo komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at 3 Months
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at 6 Months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Defecation Pain Visual Analog Scale (VAS) Score at 3 Months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NNGYK/09884-2/2026
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .