NCT04103216

Treatment of Cryptosporidiosis

Completed NA Last updated 16 October 2023

What this trial tests

NA trial testing Nitazoxanide with Lactobacillus Reuteri DSM 17938 in Cryptosporidiosis in 64 participants. Completed in 31 August 2023.

Timeline

1 February 2020

Primary endpoint
31 December 2022

31 August 2023

Quick facts

Lead sponsor	International Centre for Diarrhoeal Disease Research, Bangladesh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	64
Start date	1 February 2020
Primary completion	31 December 2022
Estimated completion	31 August 2023
Sites	1 location across Bangladesh

Drugs / interventions tested

• Nitazoxanide with Lactobacillus Reuteri DSM 17938
• Nitazoxanide (NITAZOXANIDE) — full drug profile →

Conditions studied

• Cryptosporidiosis — all drugs for Cryptosporidiosis →

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh — full company profile →

Who can join

Adults 12 Months to 36 Months, any sex, with Cryptosporidiosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

1. Burden:

Cryptosporidiosis among the top 10 causes of diarrhea in the 1st year of life in low and middle-income countries (LMICs), with an estimated total of 48,000 annual deaths and accounting for 4.2 million disability-adjusted life years lost.
2. Knowledge gap:

The only approved drug for the treatment of diarrhea caused by Cryptosporidium infection is Nitazoxanide (NTZ) but NTZ has a higher failure rate in malnourished children. The lack of effective therapy for cryptosporidiosis remains an immense knowledge gap in the efforts to improve childhood health worldwide.

Hypothesis:

NTZ treatment failure in malnourished infants is due to a secondary immune deficiency that can be reversed by the appropriate therapeutic treatment. Lactobacillus reuteri DSM 17938 can have a potential immune modulating effect by altering gut microbiome promoting NTZ action.

Objectives:

Primary:

• To develop new approaches to treat and prevent cryptosporidiosis

Secondary:

* Determination of the treatment outcome of NTZ against cryptosporidiosis in Bangladeshi children.
* Determination of the change in effectiveness of NTZ treatment in conjunction with the administration of probiotics in malnourished Bangladeshi children with cryptosporidiosis

Methods:

This will be a prospectively conducted randomized pilot study with 2 arms in children in the Mirpur (Dhaka, Bangladesh) slum area, where cryptosporidium infected children will receive Nitazoxanide treatment with or without the probiotic, Lactobacillus reuteri DSM 17938.

Outcome measures/variables:

The significance of the work lies in the ability of the study to provide new approaches to treat and prevent Cryptosporidiosis. The goal of this work is to assess the efficacy of NTZ drug in a low socioeconomic Bangladeshi population and establish new supportive therapeutic measures to the already established treatment with NTZ against in cryptosporidiosis.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Nitazoxanide and Probiotic Treatment on Bangladeshi Children with Cryptosporidiosis.
   Noor Z, Hossain B, Mithila NT, Khatun A, et al · · 2025 · cited 4× · PMID 39933176 · DOI 10.4269/ajtmh.23-0914
2. Probiotic formulations and gastro-intestinal diseases in the paediatric population: a narrative review.
   Siddiqui A, Haider R, Aaqil SI, Vohra LI, et al · · 2024 · cited 4× · PMID 38694362 · DOI 10.1097/ms9.0000000000002007