Comparative Effect of 3 Different Cranberry Extracts on Cystitis Related Urinary Comfort in Women

NCT ID: NCT04962971

Last Updated: 2022-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-02-01

Brief Summary

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Urinary discomfort includes a set of signs such as an urgent need to urinate, high frequency of urination per day, discomfort / difficulty or burning sensation when urinating, smelly urine. This urinary discomfort represents in women 2 to 5% of the reasons for consultation (Berg, 1991) and can have various etiologies but the bacterial origin is the most frequent. Cranberries are traditionally used for urinary comfort and the prevention of urinary disorders with bacterial origin.

The study objective is to collect in real life efficacy and tolerance data from the consumption of 3 cranberry extracts in order to highlight the qualitative and quantitative characteristics of these extracts which are directly involved in the improvement of urinary discomfort or situation of recurrent cystitis symptomatic episodes in women.

Detailed Description

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Conditions

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Recurrent Cystitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cranberry extract X

373 mg per Day

X

Intervention Type DIETARY_SUPPLEMENT

exocyan

Cranberry extract Y

404 mg per Day

Y

Intervention Type DIETARY_SUPPLEMENT

exocyan

Cranberry extract Z

2090 mg per Day

Z

Intervention Type DIETARY_SUPPLEMENT

exocyan

Interventions

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X

exocyan

Intervention Type DIETARY_SUPPLEMENT

Y

exocyan

Intervention Type DIETARY_SUPPLEMENT

Z

exocyan

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* having had at least 3 symptomatic episodes of cystitis (including 1 urinary tract infection confirmed by a doctor) during the last 12 months
* whose episode had a significant impact on quality of life / urinary discomfort (ACSS Dimension QoL ≥ 2)
* had a smartphone compatible with Nurstrial smartphone application (e-CRF)

Exclusion Criteria

* to be a pregnant or breastfeeding woman or planning to be pregnant within 6 months,
* currently taking any other supplementation for urinary comfort or having taken any other cranberry-based food supplement in the past 3 months,
* to be under antibiotic treatment or during the last 7 days preceding inclusion,
* have urinary discomfort with a severe impact on quality of life (ACSS QoL\> 7) during the last 24 hours prior to inclusion,
* have an allergy known to plants of the cranberry family or to one of the components of the products.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nexira

INDUSTRY

Sponsor Role collaborator

CEN Nutriment

UNKNOWN

Sponsor Role collaborator

CEN Biotech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine JUHEL

Role: STUDY_DIRECTOR

CEN Nutriment

Locations

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CEN Nutriment

Dijon, Burgundy, France

Site Status

Countries

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France

Other Identifiers

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C1635

Identifier Type: -

Identifier Source: org_study_id

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