Treatment of Cryptosporidiosis

NCT04103216 | Completed DMC

• 1 other identifier: PR-19079
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• 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.

Conditions

Cryptosporidiosis

Keywords

Cryptosporidiosis; Treatment; Bangladesh; Nitazoxanide

Outcome Measures

Primary Outcomes (1)

• To develop new approaches to treat and prevent cryptosporidiosis

  Cryptosporidium infection outcome of treatment with Nitazoxanide and probiotics in comparison Nitazoxanide treatment in children. Change from baseline cryptosporidium oocyst load in stools at day 8 will be tested by qPCR.

  Change from baseline cryptosporidium oocyst load at day 8.

Study Arms (3)

Intervention arm NItazoxanide with probiotics

ACTIVE COMPARATOR

Child will be receive the Nitazoxanide treatment for 3 days with probiotics (L reuteri DSM 17938 ) for 7days. The doses of Nitazoxanide will be twice a day for 3 days and dosage will be 5 ml every 12 hours with food. The Nitazoxanide oral suspension contain 100mg/5ml. L reuteri DSM 17938 will be 2×108 CFU and will receive 5 drops orally twice daily for a consecutive 7 days.

Other: Nitazoxanide with Lactobacillus Reuteri DSM 17938

Intervention arm Nitazoxanide with placebo

PLACEBO COMPARATOR

Child will be receive the Nitazoxanide treatment for 3 days with placebo for 7days. The doses of Nitazoxanide will be twice a day for 3 days and dosage will be 5 ml every 12 hours with food. The Nitazoxanide oral suspension contain 100mg/5ml. Placebo will receive 5 drops orally twice daily for a consecutive 7 days.

Other: Nitazoxanide

Control arm

NO INTERVENTION

Child will received the standard supportive care normally provided for Cryptosporidium infections

Interventions

Nitazoxanide with Lactobacillus Reuteri DSM 17938 OTHER

Nitazoxanide with probiotics

Intervention arm NItazoxanide with probiotics

Nitazoxanide OTHER

Nitazoxanide with placebo

Intervention arm Nitazoxanide with placebo

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children will be enrolled with cryptosporidium infection positive from Mirpur, Dhaka, Bangladesh and whose parents or legal guardian will give consent.

You may not qualify if:

• Participants with history of prior antibiotic use before enrollment
• Participants suffering from Severe Acute Malnutrition, with a WHO median weight for length Z score (WLZ) of less than -3 or having bilateral pedal edema).

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• University of Virginia: collaborator

Study Sites (1)

Icddr,B

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

Cryptosporidiosis

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Intestinal Diseases, Parasitic; Parasitic Diseases; Infections; Protozoan Infections, Animal; Parasitic Diseases, Animal; Coccidiosis; Protozoan Infections; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Animal Diseases

Study Officials

• Zannatun Noor, PhD

  Assistant Scientist, Infectious Diseases Division, icddr,b

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a prospectively conducted randomized pilot study with 3 arms in children, where cryptosporidium infected children will receive Nitazoxanide treatment with or without the probiotic, Lactobacillus reuteriDSM 17938 and the third arm will receive the standard supportive care normally provided for Cryptosporidium infections.

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 25, 2019
• Study Start: February 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: August 31, 2023
• Last Updated: October 16, 2023

Record last verified: 2023-09

Locations

BA (1)