CystitisNCT04987164

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

An observational study of Cystitis and Urinary Tract Infections, run by CEN Biotech at 2 sites in France.

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

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cystitis, Urinary Tract Infections
What is being tested?: Feminabiane CBU
Type of treatment: Pill or oral medicine
How many people: 80 participants
Where: 2 sitesFrance
Study dates: 18 Nov 2021to 4 Aug 2022
Phase: Observational
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 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Study population: The first 80 women of the CEN Nutriment (Clinical Investigation Center) volunteer panel corresponding to the selection criteria and wishing to participate in the study.

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

2 sites in 1 country.

France2 sites

CEN Nutriment
Dijon, Bourgogne-Franche-Comté, 21000
CEN Nutriment
Dijon, Burgundy, 21000

Other trials in France

About this study

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

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.

Read the detailed description

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.

Conditions: Cystitis, Urinary Tract Infections
Being tested: Feminabiane CBU
Medical subject headings: Cystitis, Urinary Tract Infections

What participants receive

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

Feminabiane CBUDietary supplement
EXTRACTS OF CRANBERRY, CINNAMON AND MICROBIOTIC STRAINS

Study groups in NCT04987164
Study group	Role	What they receive
Feminabiane CBU Consumers		Group of consumers of Feminabiane CBU : 2 tablets of Feminabiane CBU® every day, to be swallowed with a glass of water. Receives: Dietary Supplement: Feminabiane CBU
Control group		Control group of non consumers of Feminabiane CBU

What is being measured

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

Occurence of symptomatic cystitis-like episodes
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.
Measured: At week 24

Secondary outcomes (5)

Change of the quality of life related to urinary discomfort
ACCS "Quality of life" domain ranged between 0 (better) and 9 (worse)
Measured: At weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Severity of urinary discomfort
Global ACCS score ranged between 0 (better) and 39 (worse)
Measured: Every day during each urinary symptoms (Week 0 to Week 24)
Time-period without antibiotics
Measurement of the time interval between 2 antibiotic therapies if applicable
Measured: At week 24
Mean time to onset of symptomatic episodes of the cystitis
Measurement of the time interval between 2 symptomatic episodes of the cystitis
Measured: At week 24
Effect of blend consumption in preventing symptomatic episode of cystitis
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).
Measured: At week 24

Timeline

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

18 Nov 20214 Aug 2022

First posted3 Aug 2021
Study start18 Nov 2021
Primary completion4 Aug 2022
Study completion4 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CystitisStudies 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: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04987164
Sponsor's protocol ID: C1671
Status last verified: Feb 2023
First submitted: 19 Jul 2021
Last updated: 2 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Ait Abdellah S, Leblanc A, Dauchet Q, Blondeau C, Bohbot JM. Effects of a supplement associating Lactobacillus strains and proanthocyanidin-rich plant extracts against recurrent uncomplicated, urinary tract infections: A prospective, controlled study. Investig Clin Urol. 2025 Jan;66(1):36-46. doi: 10.4111/icu.20240092.
PubMed 39791583

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Study Evaluating the Number of Symptomatic Cystitis-like Episodes and Urinary Comfort of Women Consuming Cranberry, Cinnamon and Probiotic Strain Extracts
ClinicalTrials.gov ID: NCT04987164
Acronym / sponsor ID: C1671
Conditions: Cystitis, Urinary Tract Infections
Study type: Observational
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: CEN BiotechIndustry (pharma, biotech, devices)
Collaborators: PiLeJe
Study start: 18 Nov 2021 (actual)
Primary completion: 4 Aug 2022 (actual)
Study completion: 4 Aug 2022 (actual)
First posted: 3 Aug 2021 (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.

Detailed description

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.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Feminabiane CBU Consumers	–	Dietary Supplement: Feminabiane CBUGroup of consumers of Feminabiane CBU : 2 tablets of Feminabiane CBU® every day, to be swallowed with a glass of water.
Control group	–	–Control group of non consumers of Feminabiane CBU

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: The first 80 women of the CEN Nutriment (Clinical Investigation Center) volunteer panel corresponding to the selection criteria and wishing to participate in the study.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (11 listed)

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;

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
Feminabiane CBUEXTRACTS OF CRANBERRY, CINNAMON AND MICROBIOTIC STRAINS	Dietary supplement	Feminabiane CBU Consumers

Primary outcome

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.

5 secondary outcomes

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
Severity of urinary discomfort
Time frame: Every day during each urinary symptoms (Week 0 to Week 24)
Time-period without antibiotics
Time frame: At week 24
Mean time to onset of symptomatic episodes of the cystitis
Time frame: At week 24
Effect of blend consumption in preventing symptomatic episode of cystitis
Time frame: At week 24

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 2 Mar 2023.
Derived from this study: PubMed 39791583Ait Abdellah S, Leblanc A, Dauchet Q, Blondeau C, Bohbot JM. Effects of a supplement associating Lactobacillus strains and proanthocyanidin-rich plant extracts against recurrent uncomplicated, urinary tract infections: A prospective, controlled study. Investig Clin Urol. 2025 Jan;66(1):36-46. doi: 10.4111/icu.20240092.

Related trials for Cystitis

Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome

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.

JEAN-MARC BOHBOT, MD principal investigator

Institut Fournier-PARIS

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

Questions about this trial

What is this clinical trial studying?

An observational study of Cystitis and Urinary Tract Infections, run by CEN Biotech at 2 sites in France.

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 4 inclusion and 11 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 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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?

Occurence of symptomatic cystitis-like episodes (time frame: At week 24). 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 NCT04987164, which also lists 1 linked publication.

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 2 Mar 2023.