Recurrent Kidney Stones With Colicky PainNCT06477471

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.

A study testing MetProrenes in people with Recurrent Kidney Stones With Colicky Pain, run by NovoBliss Research Pvt Ltd at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Recurrent Kidney Stones With Colicky Pain
What is being tested?: MetProrenes
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteIndia
Study dates: 29 Nov 2024to 7 Jan 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

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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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

India1 site

NovoBliss Research Pvt.Ltd
Ahmedabad, Gujarat, 382481

Other trials in India

About this study

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

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

Read the 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
Being tested: MetProrenes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06477471
Study group	Role	What they receive
Recurrent Kidney Stone with Colicky Pain	Experimental	Take one slow-release capsule twice a day, after meal, orally. Receives: Other: MetProrenes

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (18)

Changes in Haemoglobin
Assessment of the safety of the test treatment in terms of abnormal changes in Haemoglobin
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Haematocrit
Assessment of the safety of the test treatment in terms of abnormal changes in Haematocrit.
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Red Blood count
Assessment of the safety of the test treatment in terms of abnormal changes in Red Blood Count.
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Packed Cell Volume
Assessment of the safety of the test treatment in terms of abnormal changes in Packed cell volume Count.
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Red Blood count morphology
Assessment of the safety of the test treatment in terms of abnormal changes in Red Blood Count morphology.
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Mean corpuscular volume
Assessment of the safety of the test treatment in terms of abnormal changes in Mean corpuscular volume
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in mean corpuscular hemoglobin
Assessment of the safety of the test treatment in terms of abnormal changes in mean corpuscular hemoglobin
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in mean corpuscular hemoglobin concentration
Assessment of the safety of the test treatment in terms of abnormal changes in mean corpuscular hemoglobin concentration
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in red blood cell distribution width
Assessment of the safety of the test treatment in terms of abnormal changes in red blood cell distribution width
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Total WBC count
Assessment of the safety of the test treatment in terms of abnormal changes in Total WBC count.
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Differential WBC count
Assessment of the safety of the test treatment in terms of abnormal changes in Differential WBC count.
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Platelet count
Assessment of the safety of the test treatment in terms of abnormal changes in Platelet count.
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in mean platelet volume
Assessment of the safety of the test treatment in terms of abnormal changes in mean platelet volume.
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Plateletcrit
Assessment of the safety of the test treatment in terms of abnormal changes in Plateletcrit.
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in platelet distribution width
Assessment of the safety of the test treatment in terms of abnormal changes in platelet distribution width.
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes inSerum Creatinine
Assessment of the safety of the test treatment in terms of abnormal changes in Serum Creatinine.
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Serum Glutamic Pyruvic Transaminase
Assessment of the safety of the test treatment in terms of abnormal changes in Serum Glutamic Pyruvic Transaminase
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Serum Glutamic-Oxaloacetic Transaminase
Assessment of the safety of the test treatment in terms of abnormal changes in Serum Glutamic-Oxaloacetic Transaminase
Measured: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Nov 20247 Jan 2025

First posted27 Jun 2024
Study start29 Nov 2024
Primary completion7 Jan 2025
Study completion7 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Recurrent Kidney Stones With Colicky PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: An Open-Label, Single-Arm, Prospective, Interventional, Proof-of-Science Study
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06477471
Sponsor's protocol ID: NB240020-MB
Status last verified: Jun 2024
First submitted: 7 Jun 2024
Last updated: 6 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06477471
Acronym / sponsor ID: NB240020-MB
Conditions: Recurrent Kidney Stones With Colicky Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: NovoBliss Research Pvt LtdUniversity, hospital or other
Collaborators: Meteoric Biopharmaceuticals Pvt. Ltd.
Study start: 29 Nov 2024 (actual)
Primary completion: 7 Jan 2025 (actual)
Study completion: 7 Jan 2025 (actual)
First posted: 27 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: An Open-Label, Single-Arm, Prospective, Interventional, Proof-of-Science Study

Arm	Type	Receives
Recurrent Kidney Stone with Colicky Pain	Experimental	Other: MetProrenesTake one slow-release capsule twice a day, after meal, orally.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MetProrenesTake one slow-release capsule twice a day, after meal.	Other	Recurrent Kidney Stone with Colicky Pain

Primary outcome

Change in the colicky pain
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
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
Changes in Urine Calcium
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Assessment of the effectiveness of the test treatment in terms of changes in Urine Calcium examined by urinalysis after 24h-urine collection
Changes in Urine Sodium
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Assessment of the effectiveness of the test treatment in terms of changes in Urine Sodium examined by urinalysis after 24h-urine collection
Changes in Urine Oxalate
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Assessment of the effectiveness of the test treatment in terms of changes in Urine Oxalate examined by urinalysis after 24h-urine collection
Changes in Urine pH
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Assessment of the effectiveness of the test treatment in terms of changes in Urine pH examined by urinalysis after 24h-urine collection
Changes in Urine R/M
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Assessment of the effectiveness of the test treatment in terms of changes in Urine R/M examined by urinalysis after 24h-urine collection

18 secondary outcomes

Changes in Haemoglobin
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Haematocrit
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Red Blood count
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Packed Cell Volume
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Red Blood count morphology
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Mean corpuscular volume
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in mean corpuscular hemoglobin
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in mean corpuscular hemoglobin concentration
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in red blood cell distribution width
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Total WBC count
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Differential WBC count
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Platelet count
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in mean platelet volume
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Plateletcrit
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in platelet distribution width
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes inSerum Creatinine
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Serum Glutamic Pyruvic Transaminase
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).
Changes in Serum Glutamic-Oxaloacetic Transaminase
Time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr. Nayan K Patel principal investigator

NovoBliss Research Pvt Ltd

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MetProrenes in people with Recurrent Kidney Stones With Colicky Pain, run by NovoBliss Research Pvt Ltd at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the colicky pain (time frame: On Day 01 (before administration) for baseline, and post-dosage on Day 14 (±2 days).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06477471.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.