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OpenTrials
Completed

NCT Number: NCT04987164

Incidence of Cystitis in Women Consuming a Mixture of Cranberry, Cinnamon, Probiotics

Cranberries are traditionally used for urinary comfort and prevention of urinary disorders of bacterial origin and despite an EFSA opinion invalidating the clinical efficacy of cranberries, its mechanism of action has been several times proposed by the scientific community: it would act by inhibiting the synthesis of P-fimbriae leading to a complete disappearance of these adhesins, and to bacterial-type deformation by lengthening of the cell body. Cinnamon and microbiotic strains could enhance this synergy.

This study aims to evaluate the effectiveness of a food supplement based on cranberry, cinnamon and microbiotic strains (Feminabiane CBU) on the symptoms of cystitis, urinary discomfort and the number of cystitis reported by women.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

CEN Nutriment, Dijon, Bourgogne-Franche-Comté, France

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About this study

Women who use or not the cranberry, cinnamon, and microbiotic blend are encouraged to complete a 6-month diary in which they report any urinary tract disorders they encounter.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having at least 2 symptomatic episodes of cystitis during the last 6 months including at least 1 episode confirmed as being bacterial cystitis (by an urine bacterial analysis or validated by a doctor (date of appointment, list of prescribed treatments) ;
  • Whose symptomatic episodes of cystitis over the past 6 months have had a significant impact on quality of life / urinary comfort (ACSS QoL> 2);
  • Having a smartphone compatible with the NURSTRIAL® data collection application;
  • Not opposing the collection and processing of their personal data.

Exclusion criteria

  • Presenting urinary discomfort with a severe impact on quality of life (ACSS QoL> 7) during the last 24 hours prior to inclusion;
  • Pregnant, breastfeeding or planning to become pregnant during the study;
  • Under antibiotic treatment (or during the last month preceding inclusion);
  • Under food supplementation with prebiotics or probiotics or having stopped it less than a month before inclusion;
  • Having had recourse to a prophylactic treatment (cranberry juice) 15 days before inclusion;
  • Having had local estrogen therapy during the 3 months preceding inclusion;
  • Diabetic;
  • Presenting an immunosuppressive disease;
  • Presenting pelvic floor abnormalities (Cystocele surgery, etc.);
  • Presenting or having a history of kidney disease (including kidney stones, urinary tract abnormalities, pyelonephritis, kidney failure, kidney transplantation);
  • For women consuming supplementation: known allergy to plants of the cranberry family or to one of the components of the products.

Treatment and study plan

Feminabiane CBU

Dietary Supplement

EXTRACTS OF CRANBERRY, CINNAMON AND MICROBIOTIC STRAINS

Primary outcomes

  1. Occurence of symptomatic cystitis-like episodes

    Time frame: At week 24

    Number of symptomatic cystitis-like episodes reported by the subject self-assessed using the "typical" domain of the Acute Cystitis Symptom Score (ACCS) and defined by a score ranged between 6 to 18.

Secondary outcomes

  1. Change of the quality of life related to urinary discomfort

    Time frame: At weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24

    ACCS "Quality of life" domain ranged between 0 (better) and 9 (worse)

  2. Severity of urinary discomfort

    Time frame: Every day during each urinary symptoms (Week 0 to Week 24)

    Global ACCS score ranged between 0 (better) and 39 (worse)

  3. Time-period without antibiotics

    Time frame: At week 24

    Measurement of the time interval between 2 antibiotic therapies if applicable

  4. Mean time to onset of symptomatic episodes of the cystitis

    Time frame: At week 24

    Measurement of the time interval between 2 symptomatic episodes of the cystitis

  5. Effect of blend consumption in preventing symptomatic episode of cystitis

    Time frame: At week 24

    Comparison of the rate of women blend users versus non-users who did not reported any symptomatic episode of cystitis as defined by a 0 score for the "typical" domain of the Acute Cystitis Symptom Score (ACCS).

Other outcomes

  1. Assessing the remanent effect of the mix on total urinary tract disorders

    Time frame: At week 32

    Total number of urinary tract disorders reported by women, compared to the 0-24 week period

  2. Assessing the remanent effect of the mix on the type urinary tract disorders

    Time frame: At week 32

    Rates of urinary tract disorders (cystitis and cystitis-like symptoms) reported by women, compared to the 0-24 week period

  3. Satisfaction with the assessed mix

    Time frame: At month 1, 2, 3, 4, 5, 6

    Mean statisfaction score using a 5-point Likert scale: 1 means worse satisfaction and 5 means the best satisfaction.

    Very satisfied=1, Somewhat satisfied=2, Neither satisfied nor dissatisfied=3, Somewhat dissatisfied=4 and Very dissatisfied=5

  4. Dietary supplementation ingestion observance

    Time frame: At weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24

    Weekly number of food supplements not ingested in relation to the expected consumption

  5. Gastrointestinal pain

    Time frame: At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24

    Visual analogic score assessing abdominal pain (0= no pain, 10= worse pain)

  6. Gastrointestinal discomfort

    Time frame: At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24

    Visual analogic score assessing bloating or flatulence (0= never, 10= always)

  7. Assessing tolerance to the ingestion of food supplements

    Time frame: At week 24

    Total number encountered of adverse events (abdominal pain, bloating, constipation) and rates of this adverse events

Sponsors and collaborators

Lead sponsor

CEN Biotech

Industry

Collaborators

  • PiLeJe

Registry information

Official study title

Observational Study Evaluating the Number of Symptomatic Cystitis-like Episodes and Urinary Comfort of Women Consuming Cranberry, Cinnamon and Probiotic Strain Extracts

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 3, 2021
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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