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Cryptosporidiosis clinical trials

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NCT ID: NCT05036668 Completed - Clinical trials for Cryptosporidium Infection, Cryptosporidiosis

Study of Efficacy and Safety of ABO809 in Healthy Participants

Start date: April 7, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this Phase I controlled human infection model (CHIM) study was to determine if oral administration of a good manufacturing practice (GMP) supply of Cryptosporidium parvum oocysts (ABO809) to healthy volunteers resulted in a Cryptosporidium infection and diarrheal illness. The study measured fecal oocysts (parasitological endpoint) as well as diarrhea and associated signs and symptoms (clinical endpoint).

NCT ID: NCT04103216 Completed - Cryptosporidiosis Clinical Trials

Treatment of Cryptosporidiosis

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT01699841 Completed - HIV Clinical Trials

Breast Milk Composition and HIV-exposed/Unexposed Early Infant Growth and Infectious Disease Events

Start date: April 2012
Phase: N/A
Study type: Observational

The purpose of this study is to understand how breast milk may protect infants from infection and promote favorable immunological, growth and development outcomes. By following mothers and their infants, we will evaluate the important interactions between infant immune responses and infectious disease events in relation to breast milk composition and feeding patterns. Our aim is to identify a set of predictive factors corresponding to healthy early infant growth and development in this setting in Northern Tanzania.

NCT ID: NCT00507871 Completed - Cryptosporidiosis Clinical Trials

Transmission and the Respiratory Tract in Cryptosporidiosis

Start date: October 2007
Phase: N/A
Study type: Observational

Cryptosporidium is an intestinal parasite that causes diarrhea in children and adults. In addition to infection of the stomach, this parasite can infect the respiratory system causing a cough and/or problems breathing. This study will enroll 480 children between the ages of 9 and 36 months who come to Mulago Hospital for treatment of diarrhea. Researchers believe a large number of children with diarrhea and cough will have the parasite present in their sputum (mucus coughed up). Researchers also believe that children who have respiratory tract cryptosporidiosis may have a cough, increased number of breaths per minute, and/or a lower oxygen level. Blood, stool, saliva, and sputum samples will be collected from all children in the study and tested for Cryptosporidium. Children too young to provide a sputum sample will have a tube placed to collect a mucus sample from the lungs. Study participation may be as short as 4 hours or as long as 2 days depending on each child's health.

NCT ID: NCT00055107 Completed - HIV Infections Clinical Trials

Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

Cryptosporidium parvum (C. parvum) is a parasite that can cause chronic diarrhea and is a significant problem for HIV infected children in developing countries. C. parvum infection can be treated with the drug nitazoxanide (NTZ). However, NTZ has not been tested in HIV infected children. The purpose of this study is to test the safety of NTZ in HIV infected children who have chronic diarrhea caused by C. parvum. Study hypothesis: Twice-daily NTZ is safe and well tolerated in HIV infected infants, children, and adolescents with chronic diarrhea caused by C. parvum infection.

NCT ID: NCT00002328 Completed - HIV Infections Clinical Trials

Azithromycin in the Treatment of Cryptosporidiosis in Patients Who Have Not Had Success With Other Drugs

Start date: n/a
Phase: N/A
Study type: Interventional

To provide azithromycin for the treatment of individual patients with proven cryptosporidiosis whose disease has persisted or progressed despite prior therapies.

NCT ID: NCT00002278 Completed - HIV Infections Clinical Trials

A 28-Day Study of Diclazuril in the Treatment of Cryptosporidiosis in Patients With AIDS

Start date: n/a
Phase: N/A
Study type: Interventional

To evaluate the safety and efficacy of diclazuril capsules as a treatment for cryptosporidial related diarrhea in AIDS patients who have been treated in the double-blind study # JRD 64,433/1101 and have relapsed, or de-novo patients who have been diagnosed with cryptosporidial related diarrhea and who meet the inclusion and exclusion criteria of this protocol.

NCT ID: NCT00002264 Completed - HIV Infections Clinical Trials

The Effectiveness of Cow's Milk Immune Globulin in the Treatment of AIDS-Related Diarrhea

Start date: n/a
Phase: N/A
Study type: Interventional

To examine the efficacy of cow's milk immune globulin in the treatment of diarrhea due to chronic intestinal cryptosporidiosis in patients with AIDS. The secondary end points of the study involve functional improvement which will be determined from nutritional and absorption studies.

NCT ID: NCT00002248 Completed - HIV Infections Clinical Trials

A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Bovine Anti-Cryptosporidium Immunoglobulin (BACI) in the Treatment of Cryptosporidium Enteritis in AIDS Patients

Start date: n/a
Phase: Phase 1
Study type: Interventional

PRIMARY: To assess the effect of bovine anti-Cryptosporidium immunoglobulin (BACI) on the volume of diarrhea due to Cryptosporidium parvum in AIDS patients who have protracted Cryptosporidium enteritis. SECONDARY: To assess changes in stool consistency and frequency, body weight, and safety in this patient population.

NCT ID: NCT00002082 Completed - HIV Infections Clinical Trials

Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study

Start date: n/a
Phase: N/A
Study type: Interventional

To evaluate the safety and efficacy of azithromycin in the treatment of intestinal cryptosporidial infection in AIDS patients.