Effect of Saccharomyces Boulardii CNCM I-745 (Sb) on Bloody Diarrhea in Children. A Double Blind, Randomized, Controlled Study ( Sb192-SUH )

Fundación Hospital de Pediatría Prof. Dr. Juan P. Garrahan

Status and phase: Active, not recruiting; Phase 4

Conditions: Acute Bloody Diarrhea of 7 Days or Less Duration

Treatments: Drug: Placebo; Drug: Saccharomyces boulardi (Sb)

Study type: Interventional

Funder types: Other

Identifiers

NCT07371819

Sb192-SUH

Details and patient eligibility

About

Acute diarrhea (AD) is one of the commonest illnesses in children. A particularly severe form of diarrhea is bloody diarrhea (BD).

Saccharomyces boulardii CNCM I-745 is a probiotic with demonstrated efficacy in children with acute diarrhea; however, evidence regarding its use in bloody diarrhea (BD) is lacking. This project aims to assess the efficacy and safety of Saccharomyces boulardii CNCM I-745 on bloody diarrhea in children.

The study objective are :

• To assess the efficacy of Sacharomyces Boulardi (SB) on acute bloody diarrhea in children aged 0 - 5 years. Indicators: duration of bloody diarrhea, daily frequency of stools with blood, daily frequency of total stools with or without blood during follow up.

• To assess the most frequent bacterial agents

• To assess the safety of the product. The study is a double blind, controlled trial (SB or placebo), with two arms parallel, randomized design, carried out on outpatient clinic because of acute bloody diarrhea.

Full description

Patients with acute bloody diarrhea were prescribed randomly and blindly placebo or Saccharomyces boulardii 500 mg /day seven days (250 mg for children between 0.25 - 1.00 years),and were seen in outpatient clinics of three hospitals at days 1, 3, and 7. On day 14 they were contacted by telephone call. Parents registered daily number of stools, with or without diarrhea, and any new symptom appearing during follow up.

Enrollment: 140 estimated patients

Sex: All

Ages: 3 to 71 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all children between 0.25 and 5.99 years
• attending emergency clinic because of acute diarrhea,
• showing stools with presence of blood,
• whose parents were adequately informed, and signed the corresponding consent

Exclusion criteria

• diarrhea lasting more than 7 days at inclusion
• presence of malnutrition and any other chronic or major disease,
• previous or concomitant intake of steroids, or other immunosuppressive drugs,
• immunocompromised

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

140 participants in 2 patient groups, including a placebo group

Treatment Arm

Experimental group

Treatment:

Drug: Saccharomyces boulardi (Sb)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo