NCT04199325

Brief Summary

Under the premise of double-blind and non-interference clinical treatment, to evaluate the clinical efficacy and safety of probiotic Lactobacillus Zhang combined with routine treatment for gout hyperuricemia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

5.1 years

First QC Date

December 12, 2019

Last Update Submit

July 18, 2023

Conditions

GoutHyperuricemia

Keywords

gouthyperuricemiaprobiotics

Outcome Measures

Primary Outcomes (1)

  • serum uric acid level

    The serum uric acid level was standard-reaching rate at the end of 24 weeks(Percentage of patients whose serum uric acid level has decreased to less than 360umol / L )

    24 weeks

Secondary Outcomes (3)

  • serum uric acid level at the 4、8、12、24 weeks

    4、8、12、24 weeks

  • serum uric acid decreased from baseline

    4、8、12、24 weeks

  • Acute attack of gout

    24 week

Study Arms (2)

Intervention group

EXPERIMENTAL
Dietary Supplement: ProbioticsDrug: uric-acid-lowering drug

Control group

PLACEBO COMPARATOR
Drug: uric-acid-lowering drug

Interventions

ProbioticsDIETARY_SUPPLEMENT

Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.

Intervention group
uric-acid-lowering drugDRUG

Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.

Control groupIntervention group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old, gender unlimited ；
  • Previous history of gout ；
  • According to the criteria of gout classification and diagnosis of EULAR / ACR in 2015；
  • fasting serum uric acid ≥ 480 μ mol / L (8mg / dl)

You may not qualify if:

  • If the subjects meet any of the following criteria, they will not be selected ：
  • Gout in the past two weeks ；
  • Secondary hyperuricemia ；
  • Patients with abnormal liver and kidney function (ALT, AST are 1.5 times higher than the normal value, Cr is 1.5 times higher than the upper limit of the normal value；
  • WBC \< 4.0 × 109 / L, PLT \< 100 × 109 / L, HGB \< 90g / L, or other hematological diseases ；
  • bad blood pressure control (BP\>160mmHg/100 mmHg)
  • Type I diabetes or poorly controlled type II diabetes: fasting blood glucose ≥ 8.5mmol/l ；
  • Patients with active peptic ulcer ；
  • Patients with gastrointestinal cancer ；
  • Patients with previous intestinal diseases such as lactose intolerance, irritable bowel syndrome, inflammatory bowel disease and habitual diarrhea ；
  • Use of drugs that affect the metabolism or excretion of uric acid and cannot / cannot be stopped, including azathioprine, 6-mercaptopterin, thiazide diuretics, aspirin (more than 325mg / day) or other salicylates ；
  • Those who need continuous prednisone treatment ；
  • Those who need antibiotic treatment for infectious diseases ；
  • Those with body mass index (BMI) greater than 30 ；
  • people with alcoholism ；
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inner Mongolia Medical College Affiliated Hospital

Hohhot, Inner Mongolia, 010000, China

RECRUITING

MeSH Terms

Conditions

GoutHyperuricemia

Interventions

Probiotics

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 13, 2019

Study Start

November 1, 2018

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

CN(1)