Comparison of Bacillus Clausii and Saccharomyces Boulardii for Acute Diarrhea at Day 3

NCT07853846 | Active Not Recruiting

• 1 other identifier: CPMC/IRB-No/1503
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

THIS STUDY WILL BE CONDUCTED ON OPD PATIENTS IN CENTRAL PARK TEACHING HOSPITAL LAHORE TO SEE THE EFFECT OF PROBIOTICS ON DIARRHEA ALL PATIENTS INCLUDED WILL HAVE ACUTE WATERY DIARRHEA AND THE OUTCOME WILL BE CHECKED ON THE THIRD DAY OF ADMISSION

Conditions

Acute Watery Diarrhea

Keywords

ACUTE DIARRHEA; PROBIOTIC; FUNGAL PROBIOTIC; BACTERIAL PROBIOTIC; ACUTE WATERY DIARRHEA

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy of probiotic treatment

  Clinical efficacy will be assessed on the 3rd day. A positive outcome will be defined as ≤3 episodes of stool with Bristol stool grade 5 or less. The clinical efficacy of Bacillus clausii will be compared with Saccharomyces boulardii in children with acute watery diarrhea.

  3 days

Study Arms (2)

BACILLUS CLAUSII

ACTIVE COMPARATOR

Participants will receive bacterial-based probiotic Bacillus clausii (2 billion spores), administered orally twice daily, in addition to standard diarrheal treatment. Participants will be followed for 3 days to assess clinical efficacy based on stool frequency and consistency.

Dietary Supplement: Bacillus clausii

SACCHROMYCES BOULARDII

ACTIVE COMPARATOR

Participants will receive fungal-based probiotic Saccharomyces boulardii 250 mg, administered orally twice daily, in addition to standard diarrheal treatment. Participants will be followed for 3 days to assess clinical efficacy based on stool frequency and consistency.

Dietary Supplement: Saccharomyces boulardii

Interventions

Bacillus clausii DIETARY_SUPPLEMENT

Bacillus clausii, a bacterial-based probiotic, will be administered orally at a dose of 2 billion spores twice daily for 3 days, in addition to standard diarrheal treatment. Clinical efficacy will be assessed on the 3rd day based on stool frequency and consistency.

BACILLUS CLAUSII

Saccharomyces boulardii DIETARY_SUPPLEMENT

Saccharomyces boulardii, a fungal-based probiotic, will be administered orally at a dose of 250 mg twice daily for 3 days, in addition to standard diarrheal treatment. Clinical efficacy will be assessed on the 3rd day based on stool frequency and consistency.

SACCHROMYCES BOULARDII

Eligibility Criteria

• Age: 0 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 0 to 59 months
• Acute Watery Diarrhea
• The child's parents or caregiver understands, agrees to participate, and complies with the study protoco

You may not qualify if:

• Patients with bloody diarrhea, severe dehydration, severe electrolyte imbalance, immunocompromised children, or malabsorption disorders and systemic illnesses (sepsis, pneumonia, urinary infections)
• Those who have already used antibiotics or probiotics during this illness
• Known hypersensitivity to probiotics

Sponsors & Collaborators

• Syeda Sabeen Fatima Naqvi: lead

Study Sites (1)

Central Park Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

• Awais M, Alam S, Wali N, Mehmood R, Nasir U, Waheed A. Comparison of the Clinical Efficacy of Bacteria-Based Probiotics to Fungi-Based Probiotics. 7.

  BACKGROUND

• Sharif A, Ardakani AT, Kashani HH, Rabiee F, Sharif MR. Comparison Efficacy of Bacterial and Fungal Probiotics on Acute Pediatric Diarrhea A Randomized Clinical Trial [Internet]. 2019 [cited 2024 Sept 3]. Available from: https://www.researchsquare.com/article/rs-2183/v1

  BACKGROUND

• Erdogan O, Tanyeri B, Torun E, Gonullu E, Arslan H, Erenberk U, Oktem F. The comparition of the efficacy of two different probiotics in rotavirus gastroenteritis in children. J Trop Med. 2012;2012:787240. doi: 10.1155/2012/787240. Epub 2012 Jun 19.

  PMID: 22778754 BACKGROUND

• Khan MH, Khan MS. Comparison of Multispecies Probiotic and Saccahomyces Boulardii in Children with Acute Watery Diarrhea in Terms of Mean Duration of Diarrhea.

  BACKGROUND

• Sharma AK, Puri N, Mathur M, Mathur A. A randomized controll trial to compare the efficacy of saccharomyces boulardii, bacillus clausii, and lactobacillus rhamnosus GG preparation in the treatment of acute diarrhea in children. Asian J Pharm Clin Res. 2022 Mar 14;63-7.

  BACKGROUND

• Syed M, Gondi S, D V, P U. Study on efficacy of probiotic use in pediatric acute diarrhea: A prospective open-labeled study. Natl J Physiol Pharm Pharmacol. 2023;14(5):1

  BACKGROUND

MeSH Terms

Interventions

clausin peptide, Bacillus clausii

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Trainee Registrar Pediatric medicine

Model Details: Participants will be randomly assigned to one of two parallel treatment groups. Group A will receive Bacillus clausii and Group B will receive Saccharomyces boulardii, both in addition to standard diarrheal treatment.

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: October 2, 2026
• Study Start: July 2, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

PA (1)