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.

NCT ID: NCT06477471

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-30
• Study Completion Date: 2024-08-13

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.

Conditions

Recurrent Kidney Stones With Colicky Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Recurrent Kidney Stone with Colicky Pain

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

Group Type: EXPERIMENTAL

MetProrenes

Intervention Type: OTHER

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

Interventions

MetProrenes

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Meteoric Biopharmaceuticals Pvt. Ltd.

INDUSTRY

Sponsor Role: collaborator

NovoBliss Research Pvt Ltd

OTHER

Sponsor Role: lead

Responsible Party

Dr Nayan Patel

Principal Investigator- Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Nayan K Patel

Role: PRINCIPAL_INVESTIGATOR

NovoBliss Research Pvt Ltd

Central Contacts

Maheshvari N Patel

Role: CONTACT

maheshvari@novobliss.in

09909013236

Sheetal J Khandwala

Role: CONTACT

bd@novobliss.in

Other Identifiers

NB240020-MB

Identifier Type: -

Identifier Source: org_study_id