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.

NCT06477471 | Not Yet Recruiting

• 1 other identifier: NB240020-MB
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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

Conditions

Recurrent Kidney Stones With Colicky Pain

Outcome Measures

Primary Outcomes (6)

• Change in the colicky pain

  Evaluate the effect of the test treatment in term of change in the colicky pain determined using the VAS scoring where 0 indicates no pain and 10 indicates severe pain

  On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).

• Changes in Urine Calcium

  Assessment of the effectiveness of the test treatment in terms of changes in Urine Calcium examined by urinalysis after 24h-urine collection

  On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).

• Changes in Urine Sodium

  Assessment of the effectiveness of the test treatment in terms of changes in Urine Sodium examined by urinalysis after 24h-urine collection

  On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).

• Changes in Urine Oxalate

  Assessment of the effectiveness of the test treatment in terms of changes in Urine Oxalate examined by urinalysis after 24h-urine collection

  On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).

• Changes in Urine pH

  Assessment of the effectiveness of the test treatment in terms of changes in Urine pH examined by urinalysis after 24h-urine collection

  On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).

• Changes in Urine R/M

  Assessment of the effectiveness of the test treatment in terms of changes in Urine R/M examined by urinalysis after 24h-urine collection

  On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).

Secondary Outcomes (18)

• Changes in Haemoglobin

  On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).

• Changes in Haematocrit

  On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).

• Changes in Red Blood count

  On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).

• Changes in Packed Cell Volume

  On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).

• Changes in Red Blood count morphology

  On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).

Study Arms (1)

Recurrent Kidney Stone with Colicky Pain

EXPERIMENTAL

Take one slow-release capsule twice a day, after meal, orally.

Other: MetProrenes

Interventions

MetProrenes OTHER

Take one slow-release capsule twice a day, after meal.

Recurrent Kidney Stone with Colicky Pain

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject is an adult aged between 18 to 55 years old.
• The subject has a history of recurrent kidney stone colic or acute episode of colicky pain on clinical examination by Physician.
• Subject having refrigerator at their home for storage of test product.
• 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.
• 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.
• The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
• If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation.
• 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).
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Meteoric Biopharmaceuticals Pvt. Ltd.: collaborator

Study Officials

• Dr. Nayan K Patel

  NovoBliss Research Pvt Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maheshvari N Patel

CONTACT

09909013236; maheshvari@novobliss.in

Sheetal J Khandwala

CONTACT

bd@novobliss.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator- Medical Director

Model Details: An Open-Label, Single-Arm, Prospective, Interventional, Proof-of-Science Study

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 27, 2024
• Study Start: July 30, 2024
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share