EndometriosisENDO-DIETNCT05387161
Evaluation of Nutritional Status, Eating Habits and Improvement of Symptoms With a Nutritional Intervention in Women With enDometriosis
An observational study of Endometriosis, run by University of Pavia at 1 site in Italy.
Trial summary
The study aims to investigate the nutritional status and eating habits of women suffering from endometriosis and chronic pelvic pain in relation to describe the possible improvement of clinical symptoms following a nutritional intervention. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Nutritional intervention
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2020to 30 Dec 2023
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Study population: All patients referred to the Endometriosis Outpatient Clinic of the Gynecological Clinic of the San Matteo Polyclinic in Pavia will be enrolled and will agree to participate in the study and have signed the relative informed consent.
Who may be able to join
- Clinical diagnosis of endometriosis +/- chronic pelvic pain
- No menopause (at least 1 menstrual cycle in the previous 6 months)
- Informed consent from the patient and / or an authorized legal representative
Who cannot join
- Postmenopause
- Pregnancy
- Hysterectomy or oophorectomy
- Chronic diseases that affect the gastrointestinal absorption of nutrients (celiac disease, Chron's disease, ulcerative colitis, cystic fibrosis)
- History of kidney stones, cancer (except basal cell carcinoma) or diabetes
- Modification in the course of the therapeutic intervention of the therapy for endometriosis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Pavia
Pavia, 27100
Cinzia Ferraris, PhD, +39 0382987868, cinzia.ferraris@unipv.it
Barbara Gardella, Dott.
About this study
Official title: Evaluation of Nutritional Status, Eating Habits and Improvement of Symptoms With a Nutritional Intervention in Women With enDometriosis and chrOnic Pelvic Pain
The study aims to investigate the nutritional status and eating habits of women suffering from endometriosis and chronic pelvic pain in relation to describe the possible improvement of clinical symptoms following a nutritional intervention.
The primary aim is to describe and evaluate the impact of nutritional intervention on clinical symptoms (pain, quality of life and intestinal function) in women suffering from endometriosis with chronic pelvic pain.
Read more
The first secondary aim will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some specific areas of the patients (sexual, psychological) together with the quantification of some routine blood chemistry parameters (inflammatory markers, levels of proteins and vitamins) .
The second secondary objective will be aimed at describing the changes in clinical symptoms and the parameters mentioned above in patients based on the severity/stage of the pathologies under study.
- Conditions
- Endometriosis
- Being tested
- Nutritional intervention
- Keywords
- endometriosis, diet, inflammation, chronic pelvic pain
- Medical subject headings
- Endometriosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional interventionOther
The nutritional intervention will consist in providing general nutritional indications specific for endometriosis and an indicative ungrammatical daily diet plan, which must be followed for the entire period of intervention (6 months).
| Study group | Role | What they receive |
|---|---|---|
| Observational group | A nutritional assessment will be held with the detection of anthropometric parameters. Each participant will be asked to fill in the SF36, the VAS scales, the KESS questionnaire, the SFFI questionnaire, the Questionnaire PUF and O'Leary/Santn, the BDI and the TAS for an assessment of the psychological component.
In addition, patients will be asked to fill in a FFQ of food consumption and a 7 days food diary. Finally, routine blood chemistry tests will also be performed, to which will be added those for measuring the inflammatory state and stool examination for the evaluation of fecal Calprotectin for the measurement of intestinal inflammatory markers.
The nutritional intervention will consist in providing general nutritional indications specific for endometriosis and an indicative daily diet plan, which must be followed for 6 months.
At the end of the 6 months, all anthropometric assessments, blood chemistry and stool tests will be repeated, together with the questionnaires. Receives: Other: Nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to describe and evaluate the impact of nutritional intervention on clinical symptoms (pain, quality of life and intestinal function) in women suffering from endometriosis with chronic pelvic pain.
The outcome will be assessed with repeated measurements using the following parameters:
-Evaluation of chronic pelvic pain, dysmenorrhea, dyschezia and dysuria: VAS visual analogue scale, from 0 to 10 points where 10 points indicates worst pain
Measured: 6 months
The primary outcome is to describe and evaluate the impact of nutritional intervention on clinical symptoms (quality of life) in women suffering from endometriosis with chronic pelvic pain.
The outcome will be assessed with repeated measurements using the following parameters:
Quality of life: measurement of physical and mental components with SF36 consisting of two components, one physical and one mental. Both fall within a range from 0 to 100 points where higher values are associated with better health
Measured: 6 months
The primary outcome is to describe and evaluate the impact of nutritional intervention on clinical symptoms (intestinal function) in women suffering from endometriosis with chronic pelvic pain.
The outcome will be assessed with repeated measurements using the following parameters:
Bowel Function: Knowles-Eccersley-Scott Symptom Questionnaire (KESS) (points)
Measured: 6 months
Secondary outcomes (8)
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Sexual Function
The outcomes necessary to respond to the secondary objective are the administration of the following questionnaire:
Sexual Function: FSFI questionnaire (points)
Measured: 6 months
To describe and evaluate the impact of the nutritional intervention by describing the changes in Urinary function and bladder pain
The outcomes necessary to respond to the secondary objective are the administration of the following questionnaire:
Urinary function and bladder pain: PUF and O's Leary / Sant questionnaire (points)
Measured: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Psychological component about Depression
The outcomes necessary to respond to the secondary objective are the administration of the following questionnaire:
Beck Depression Inventory (BDI) (points)
Measured: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Psychological component
The outcomes necessary to respond to the secondary objective are the administration of the following questionnaires:
Alexithymia Scale (TAS) questionnaire (points)
Measured: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some routine blood chemistry parameters
The outcomes necessary to respond to the secondary objective are the administration of the following routine blood chemistry parameters:
Measure Ca125 (unità/ml) and Vitamin D (ng/ml)
Measured: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Intestinal inflammatory marker
The outcomes necessary to respond to the secondary objective are the administration of the following test:
fecal calprotectin (mg/kg)
Measured: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some Inflammatory markers
The outcomes necessary to respond to the secondary objective are the administration of the following Inflammatory markers: IL-6 and IL-1β values (pg/ml)
Measured: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in measurement of proteins
The outcomes necessary to respond to the secondary objective are the administration of the following measurement of proteins: C-reactive protein values (mg/dL)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Sep 2020
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Principal investigator, Cinzia Ferraris, University of Pavia
- Investigators
- Barbara Gardella, Dott, Study director, IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387161
- Sponsor's protocol ID
- 2021-ENDODIET
- Acronym
- ENDO-DIET
- Status last verified
- May 2023
- First submitted
- 24 Jan 2022
- Last updated
- 11 May 2023
- 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 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nutritional Status, Eating Habits and Improvement of Symptoms With a Nutritional Intervention in Women With enDometriosis and chrOnic Pelvic Pain
- ClinicalTrials.gov ID
- NCT05387161
- Acronym / sponsor ID
- ENDO-DIET / 2021-ENDODIET
- Conditions
- Endometriosis
- Keywords
- endometriosis, diet, inflammation, chronic pelvic pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 24 May 2022 (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.
The study aims to investigate the nutritional status and eating habits of women suffering from endometriosis and chronic pelvic pain in relation to describe the possible improvement of clinical symptoms following a nutritional intervention.
The primary aim is to describe and evaluate the impact of nutritional intervention on clinical symptoms (pain, quality of life and intestinal function) in women suffering from endometriosis with chronic pelvic pain.
The first secondary aim will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some specific areas of the patients (sexual, psychological) together with the quantification of some routine blood chemistry parameters (inflammatory markers, levels of proteins and vitamins) .
The second secondary objective will be aimed at describing the changes in clinical symptoms and the parameters mentioned above in patients based on the severity/stage of the pathologies under study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Other: Nutritional interventionA nutritional assessment will be held with the detection of anthropometric parameters. Each participant will be asked to fill in the SF36, the VAS scales, the KESS questionnaire, the SFFI questionnaire, the Questionnaire PUF and O'Leary/Santn, the BDI and the TAS for an assessment of the psychological component. In addition, patients will be asked to fill in a FFQ of food consumption and a 7 days food diary. Finally, routine blood chemistry tests will also be performed, to which will be added those for measuring the inflammatory state and stool examination for the evaluation of fecal Calprotectin for the measurement of intestinal inflammatory markers. The nutritional intervention will consist in providing general nutritional indications specific for endometriosis and an indicative daily diet plan, which must be followed for 6 months. At the end of the 6 months, all anthropometric assessments, blood chemistry and stool tests will be repeated, together with the questionnaires. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients referred to the Endometriosis Outpatient Clinic of the Gynecological Clinic of the San Matteo Polyclinic in Pavia will be enrolled and will agree to participate in the study and have signed the relative informed consent.
Key inclusion criteria (3 listed)
- Clinical diagnosis of endometriosis +/- chronic pelvic pain
- No menopause (at least 1 menstrual cycle in the previous 6 months)
- Informed consent from the patient and / or an authorized legal representative
Key exclusion criteria (6 listed)
- Postmenopause
- Pregnancy
- Hysterectomy or oophorectomy
- Chronic diseases that affect the gastrointestinal absorption of nutrients (celiac disease, Chron's disease, ulcerative colitis, cystic fibrosis)
- History of kidney stones, cancer (except basal cell carcinoma) or diabetes
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 |
|---|---|---|
| Nutritional interventionThe nutritional intervention will consist in providing general nutritional indications specific for endometriosis and an indicative ungrammatical daily diet plan, which must be followed for the entire period of intervention (6 months). | Other | Observational group |
Primary outcome
The primary outcome is to describe and evaluate the impact of nutritional intervention on clinical symptoms (pain, quality of life and intestinal function) in women suffering from endometriosis with chronic pelvic pain.
Time frame: 6 months
The outcome will be assessed with repeated measurements using the following parameters: -Evaluation of chronic pelvic pain, dysmenorrhea, dyschezia and dysuria: VAS visual analogue scale, from 0 to 10 points where 10 points indicates worst pain
The primary outcome is to describe and evaluate the impact of nutritional intervention on clinical symptoms (quality of life) in women suffering from endometriosis with chronic pelvic pain.
Time frame: 6 months
The outcome will be assessed with repeated measurements using the following parameters: Quality of life: measurement of physical and mental components with SF36 consisting of two components, one physical and one mental. Both fall within a range from 0 to 100 points where higher values are associated with better health
The primary outcome is to describe and evaluate the impact of nutritional intervention on clinical symptoms (intestinal function) in women suffering from endometriosis with chronic pelvic pain.
Time frame: 6 months
The outcome will be assessed with repeated measurements using the following parameters: Bowel Function: Knowles-Eccersley-Scott Symptom Questionnaire (KESS) (points)
8 secondary outcomes
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Sexual Function
Time frame: 6 months
To describe and evaluate the impact of the nutritional intervention by describing the changes in Urinary function and bladder pain
Time frame: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Psychological component about Depression
Time frame: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Psychological component
Time frame: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some routine blood chemistry parameters
Time frame: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Intestinal inflammatory marker
Time frame: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some Inflammatory markers
Time frame: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in measurement of proteins
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No
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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.
Barbara Gardella, Dott study director
IRCCS Policlinico San Matteo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by University of Pavia at 1 site in Italy.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 May 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cinzia Ferraris, PhD (3402337242, cinzia.ferraris@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is to describe and evaluate the impact of nutritional intervention on clinical symptoms (pain, quality of life and intestinal function) in women suffering from endometriosis with chronic pelvic pain. (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2023.