To investigate the effectiveness of an anti-inflammatory diet in reducing pain symptoms among patients with endometriosis and to explore whether the addition of CBT enhances this pain-reducing effect apart from the effect of CBT alone. The secondary…
ID
Source
Brief title
Condition
- Ovarian and fallopian tube disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the change in HRQoL (as measured by the
Endometriosis Health Profile (EHP)-30 and Short Form (SF)-36, as well as a
general rating) and pain symptoms (as measured by a Numerical Rating Scale
(NRS)).
Secondary outcome
1. Evaluate the impact of the anti-inflammatory diet on improving the quality
of life in patients with endometriosis.
2. Evaluate the impact of CBT on improving the quality of life in patients with
endometriosis.
3. Investigate the influence of the anti-inflammatory diet on inflammatory
markers in peripheral blood, menstrual effluent, and the vaginal and intestinal
microbiome among patients with endometriosis.
4. Investigate the influence of CBT on inflammatory markers in peripheral
blood, menstrual effluent, and the vaginal an intestinal microbiome among
patients with endometriosis.
5. Assess the changes in Natural Killer (NK) cell populations in menstruum as a
result of implementing the anti-inflammatory diet in patients with
endometriosis.
6. Assess the changes in Naturel Killer (NL) cell populations in menstruum as a
result of implementing CBT in patients with endometriosis.
7. Examine the feasibility of long-term adherence to the anti-inflammatory diet
among patients with endometriosis.
8. Determine the effectiveness of CBT in enhancing pain reduction and overall
quality of life when combined with the anti-inflammatory diet in patients with
endometriosis.
9. To investigate whether pain intensity, pain cognitions, perceived stress,
fatigue and objectively measured cortisol levels represent the effects of CBT
on QoL in all three groups.
10. To investigate whether CBT serves as a stimulus to promote adherence to the
anti-inflammatory diet in patients with endometriosis and whether this
reinforces pain-reducing effects.
11. Investigating whether biological data, such as epigenetics and the
microbiome, can be used to predict the response to dietary interventions and
disease severity.
12. To evaluate the differences in stress (measured by hair cortisol levels),
inflammatory markers in peripheral blood, menstrual effluent, and the vaginal
and intestinal microbiome between HC and endometriosis patients.
Background summary
Treatment for endometriosis is often partially or temporarily effective. In
addition, medical hormonal treatment is associated with side effects and
interferes with fertility. Surgical treatment has a relatively high risk of
complications. Therefore, it is crucial to support people with endometriosis
through lifestyle interventions. Changing dietary patterns gives patients a
means to influence their symptoms. Our hypothesis is that an anti-inflammatory
diet could improve immune cell function and reduce inflammation, resulting in
improved health-related quality of life (HRQoL) and pain scores. In addition,
the integration of cognitive behavioral therapy (CBT) aims to provide insight
into pain mechanisms and assist in sustaining dietary modifications.
Study objective
To investigate the effectiveness of an anti-inflammatory diet in reducing pain
symptoms among patients with endometriosis and to explore whether the addition
of CBT enhances this pain-reducing effect apart from the effect of CBT alone.
The secondary objective is to investigate the effect of an anti-inflammatory
diet, CBT and the combination of these two interventions on inflammatory
characteristics in serum and menstruum samples as well as the effect on the gut
and vaginal microbiome. In addition, we want to investigate the differences in
stress (measured by hair cortisol levels), inflammatory markers in peripheral
blood, menstrual effluent, and the vaginal and intestinal microbiome between
healthy controls (HC) and endometriosis patients.
Study design
This study will be a 13-week trial with a pre-post design (T0 to T1) during
which endometriosis patients will be randomized between standard care (control
group), receive standard care and adhere to an anti-inflammatory diet (DI
group), receive standard care and CBT (CBT-group) or receive standard care,
adhere to an anti-inflammatory diet and receive CBT (DI + CBT group).
Intervention
Subjects will follow an anti-inflammatory diet based on the Dutch Dietary
Guidelines for 13 weeks. They will receive personalized dietary advice from a
dietician and recipes will be available. CBT will administered in a total of
seven individual sessions led by a psychotherapist. The content of the CBT will
be psycho-education regarding pain mechanisms and DI.
Study burden and risks
For this study, subjects need to visit the hospital two times in three months.
During these visits, blood samples will be drawn and 3 cm of hair will be
taken, subjects will hand over their samples of menstrual effluent, vaginal
swab and feces. In addition, subjects will be asked to complete several
questionnaires. Depending on which group subjects are assigned to, subjects
will have four consults with a dietician and seven individual sessions of CBT.
Since the investigational treatment consists of dietary advice based on the
Dutch Dietary Guidelines, there are no risks for the subjects. For the CBT we
expect that the intervention has a negligible risk although it could be a
potential psychological burden for subjects to undergo CBT sessions. However,
we expect that this study will be beneficial to subjects since we expect that
DI and CBT will increase HRQoL and pain symptoms might improve.
Geert Grooteplein 11
Nijmegen 6500 HB
NL
Geert Grooteplein 11
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with endometriosi via ultrasound/MRI/surgery*
- Pain NRS score > 4
- Age from 17 years
- Premenopausal status
- Body Mass Index (BMI) 18-30 kg/m2
- Ability to understand the explanation about the diet intervention (DI) and
CBT*
- Willing to follow the DI*
- Willing to continue their use of food supplements
- Willing to undergo CBT*
- Willing to collect menstrual effluent
* Not apllicable for healthy controls
Exclusion criteria
- Recurrent miscarriages (> 2)
- Eating disorder
- Diagnosed with Crohn*s disease, Ulcerative Colitis, short bowel syndrome or
another chronic inflammatory disease
- Self-reported celiac disease
- Vegan diet
- Smoking
- Use of immunosuppressive or psychotropic medication
- Score on FFQ > 130
- Diagnosed with severe mental disorder currently requiring treatment by
psychiatrist
- NRS average score below 4 during the last month
- Participation in another intervention study
- Unable to speak Dutch or to understand the intervention
- Need for surgery during the participation in the study
- Serious pain (NRS > 4) from other origin than endometriosis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06332560 |
| CCMO | NL86247.091.24 |