Clinical trial NCT06477471: A Clinical Study to Determine the Safety and Efficacy of An Oral Probiotic. Supplementation in Reducing the Risk of Kidney Stone in Adults With Recurrent Kidney Stone Colic or Acute Episode of Colicky Pain.
Official title: A Preliminary Investigation of the Safety and Effectiveness of Oral Probiotics Supplementation for Reducing the Risk of Kidney Stone in Adults With Recurrent Kidney Stone Colic or Acute Episode of Colicky Pain: An Open-Label, Single-Arm, Prospective, Interventional, Proof-of-Science Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Recurrent Kidney Stones With Colicky Pain
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
Collaborators: name: Meteoric Biopharmaceuticals Pvt. Ltd.
First posted: 2024-06-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An Open-Label, Single-Arm, Prospective, Interventional, Proof-of-Science Study
Primary purpose: TREATMENT

Brief summary: A Preliminary Investigation of the Safety and Effectiveness of Oral Probiotics Supplementation for Reducing the Risk of Kidney Stone in Adults with Recurrent Kidney Stone Colic or Acute Episode of Colicky Pain: An Open-Label, Single-Arm, Prospective, Interventional, Proof-of-Science Study.

14 adults, with recurrent kidney stone colic or acute episode of colicky pain will be enrolled to ensure 12 subjects complete the study

Detailed description: Potential subjects will undergo screening based on predefined inclusion and exclusion criteria only after obtaining written informed consent.

Subjects shall be instructed to visit the facility for the following scheduled visits:

* Visit 01 \[Day 01\]: Screening, baseline evaluations, enrolment and test treatment dispensing.
* Visit 02 \[Day 14 (± 2 days)\]: Treatment End, Follow-up Evaluations.

Eligibility criteria: Inclusion Criteria:

1. The subject is an adult aged between 18 to 55 years old.
2. The subject has a history of recurrent kidney stone colic or acute episode of colicky pain on clinical examination by Physician.
3. Subject having refrigerator at their home for storage of test product.
4. The subject is willing to provide written informed consent and comply with study procedures, including overnight stay for 24 hours at the study centre during both visits.
5. The subject is willing to abide by the study protocol and restrictions, including abstaining from using any other oral or topical treatments for kidney stone colic during the study period.
6. The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
7. If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation.

   1. Females of childbearing potential must practice and maintain an established method of birth control (e.g., IUD, hormonal implant device/injection, birth control pills, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).
   2. Non-childbearing potential females who are surgically sterile, post-menopausal for at least 1 year, or have had a tubal ligation, must have been using hormonal contraception for at least 6 months and agree to continue using the same contraception for the study duration.

Exclusion Criteria:

1. The subject has a history of severe renal impairment or chronic kidney disease.
2. The subject is pregnant/lactating, or is planning on become pregnant during the course of the study.
3. The subject has presence of significant medical or psychiatric conditions that may interfere with study participation or interpretation of results.
4. The subject has a history of substance abuse or dependence.
5. The subject has severe systemic complications of viral infections, cardiovascular disorders, neurological disorders, renal disorders, or autoimmune disorders.
6. The subject has participated in clinical studies or received any investigational agent in the previous 30 days.
7. The subject has any condition that, in the investigator's judgment, would compromise the subject's safety or study integrity.

Primary outcomes:
measure: Change in the colicky pain
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in Urine Calcium
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in Urine Sodium
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in Urine Oxalate
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in Urine pH
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in Urine R/M
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Secondary outcomes:
measure: Changes in Haemoglobin
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in Haematocrit
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in Red Blood count
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in Packed Cell Volume
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in Red Blood count morphology
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in Mean corpuscular volume
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in mean corpuscular hemoglobin
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in mean corpuscular hemoglobin concentration
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in red blood cell distribution width
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in Total WBC count
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in Differential WBC count
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in Platelet count
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in mean platelet volume
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in Plateletcrit
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in platelet distribution width
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes inSerum Creatinine
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in Serum Glutamic Pyruvic Transaminase
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
measure: Changes in Serum Glutamic-Oxaloacetic Transaminase
timeFrame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Other outcomes:
Locations:
Study officials:
affiliation: NovoBliss Research Pvt Ltd
name: Dr. Nayan K Patel
role: PRINCIPAL_INVESTIGATOR
References: