Nutritional Intervention for Endometriosis

Endometriosis Clinical Trial

Official title:

A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05175248
• Other study ID #: Pro00059650
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: August 2025

Study information

• Verified date: November 2023
• Source: Physicians Committee for Responsible Medicine
• Contact: Macy Sutton, MS
• Phone: 202-527-7385
• Email: msutton[@]pcrm.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In a 12-week parallel study, women with a verified diagnosis of endometriosis will be randomly assigned to follow a low-fat plant-based diet or to stay on their usual diets for 12 weeks. Participants in both groups will be asked to make no changes to their exercise patterns for the study period. Changes in pain, quality of life, and inflammatory biomarkers from baseline to final will be the primary outcomes. Secondary outcomes will include changes in body weight, blood lipids, gut microbiome composition, and hormonal changes.

Description:

Endometriosis is a chronic, painful condition that affects 5-10% of reproductive aged women. It is characterized by the presence of endometrial cells outside the uterus, causing pain and infertility. Current therapies to temporarily control symptoms include surgery and medical options with significant side effects. Women with endometriosis may have several surgeries by their mid-20s. The medical costs associated with endometriosis in the US alone are about $3.6 billion annually, and the total annual health care cost associated with endometriosis in 2002 was $22 billion, one-third of which is direct health care costs, with two-thirds attributed to loss of productivity. Diet may play important roles in endometriosis through its effect on circulating estrogen concentrations and inflammatory processes. Reduced fat intake and increased fiber intake have been shown to reduce estrogen levels, a key determinant of endometriosis activity. Some evidence suggests a pathogenic role for the gut microbiome, which influences the mucosal immune system and pelvic inflammation. The microbiome is responsive to short term dietary intervention, although long term changes have not been well characterized. Therefore, the investigators propose a novel intervention strategy using a plant-based diet to improve pain, inflammation, and quality of life. The morbidity caused by endometriosis is substantial in terms of pain, reduced quality of life, lost productivity, and effects on relationships. Current medical therapies are limited in efficacy and have major side effects. Typical palliative surgery does not cure endometriosis. Better understanding of diet's ability to influence the disease process has the potential to improve quality of life and daily functioning without the cost and side effects of current therapies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Women with a surgical, imaging, or clinical diagnosis of endometriosis

2. Age 18-45 years

3. Stable health condition and medications for past 3 months

4. Modified Biberoglu and Behrman (B&B) pelvic pain score of at least 5/9

5. Able to follow a plant-based diet for 12 weeks

6. Willing to be randomly assigned to either a plant-based group or a control group that will not make any dietary changes for 12 weeks

Exclusion Criteria:

1. Body mass index = 40 kg/m2

2. Smoking or drug abuse during the past six months

3. Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use

4. Unstable medical or psychiatric illness

5. Already following a plant-based diet

6. Pregnant or breastfeeding, or plans of pregnancy within the study period

7. Hysterectomy or ovariectomy

8. Fibroids, ovarian cysts, pelvic inflammatory disease

9. Endocrine inflammatory conditions, such as Cushing's syndrome, Hashimoto's thyroiditis, Graves' disease, type 1 diabetes mellitus, and Addison's disease

10. Lack of English fluency

11. Unable or unwilling to participate in all components of the study

12. Evidence of an eating disorder

Related Conditions & MeSH terms

• Endometriosis

Intervention

Behavioral:
• Plant-based Intervention Group
Participants in the intervention group will be instructed in ways to adopt a plant-based diet, use appropriate methods of food preparation, and make meals enjoyable and appetizing. The plant-based diet primarily emphasizes whole grains, vegetables, beans and legumes, and fruits. Animal products and added oils will be proscribed and the use of ultra-processed foods, sugar, and sugar-sweetened beverages will be discouraged. Fat intake will be limited to 20-30 g/day.

Locations

Country	Name	City	State
United States	Physicians Committee for Responsible Medicine	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Physicians Committee for Responsible Medicine

Country where clinical trial is conducted

United States, 

References & Publications (25)

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Ivanov II, Frutos Rde L, Manel N, Yoshinaga K, Rifkin DB, Sartor RB, Finlay BB, Littman DR. Specific microbiota direct the differentiation of IL-17-producing T-helper cells in the mucosa of the small intestine. Cell Host Microbe. 2008 Oct 16;4(4):337-49. doi: 10.1016/j.chom.2008.09.009. — View Citation

Kennedy S, Bergqvist A, Chapron C, D'Hooghe T, Dunselman G, Greb R, Hummelshoj L, Prentice A, Saridogan E; ESHRE Special Interest Group for Endometriosis and Endometrium Guideline Development Group. ESHRE guideline for the diagnosis and treatment of endometriosis. Hum Reprod. 2005 Oct;20(10):2698-704. doi: 10.1093/humrep/dei135. Epub 2005 Jun 24. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Biberoglu and Behrman Scale: change from baseline	Endometriosis-specific pain scale will be used. For inclusion in study, participants require a score of at least 5/9.	at baseline and at 12 weeks
Primary	Endometriosis Health Profile (EHP-30): change from baseline	The EHP-30 questionnaire is the only validated quality of life questionnaire for the use in endometriosis.	at baseline and at 12 weeks
Primary	Inflammatory biomarkers: change from baseline	Blood tests for biomarkers of inflammation (hsCRP, TNF-alpha, IL-1 beta and IL-6).	at baseline and at 12 weeks
Secondary	Body weight: change from baseline	Weight will be measured using a self-calibrating scale (Renpho).	at baseline and at 12 weeks
Secondary	Blood lipids: change from baseline	Change in blood lipids assessed via blood tests including lipid panels.	at baseline and at 12 weeks
Secondary	Estrogen levels: change from baseline	Estradiol, free estradiol, and sex hormone binding globulin (SHBG) will be measured through blood tests.	at baseline and at 12 weeks
Secondary	Gut microbiome composition: change from baseline	Participants will collect stool samples for microbiome analysis. Sample collection will be carried out using home collection procedures with samples returned through local post. The participants will apply a small smear to the tips of a swab from used toilet paper. The swab will, in turn, be used to transfer the smear to a fecal occult blood test (FOBT) card that will be returned by mail to a laboratory for analysis.	at baseline and at 12 weeks
Secondary	Biomarkers of endometriosis and inflammation: change from baseline	Plasma levels of brain-derived neurotrophic factor (BDNF) and IL-10 will be measured through blood tests.	at baseline and at 12 weeks