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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.

ConditionRecurrent Kidney Stones With Colicky Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNovoBliss Research Pvt Ltd

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • MetProrenes

    Other intervention

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

Treatment groups

14 Participants
are divided into 1 treatment group
Group A: Recurrent Kidney Stone with Colicky PainExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

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

Time frame
On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
3

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

Time frame
On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
4

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

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

Secondary outcomes

1

Changes in Haemoglobin

Assessment of the safety of the test treatment in terms of abnormal changes in Haemoglobin

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

Changes in Haematocrit

Assessment of the safety of the test treatment in terms of abnormal changes in Haematocrit.

Time frame
On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
3

Changes in Red Blood count

Assessment of the safety of the test treatment in terms of abnormal changes in Red Blood Count.

Time frame
On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
4

Changes in Packed Cell Volume

Assessment of the safety of the test treatment in terms of abnormal changes in Packed cell volume Count.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NovoBliss Research Pvt Ltd

Lead sponsor

Meteoric Biopharmaceuticals Pvt. Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: