Trials / Completed
CompletedNCT05714189
The Effect of Dietary Interventions, or no Intervention, on Pain and Quality of Life in Women Diagnosed With Endometriosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Amsterdam UMC, location VUmc · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This prospective pilot study was performed to explore the influence of a dietary intervention, the Low FODMAP diet or endometriosis diet, on endometriosis-related pain and Quality of Life (QoL). Participants could choose between adherence to a diet; the Low FODMAP diet or endometriosis diet, or to contribute to the control group and not adhere to a diet.
Detailed description
This prospective pilot study was performed to explore the influence of a dietary intervention, the Low FODMAP diet or endometriosis diet, on endometriosis-related pain and Quality of Life (QoL). Participants could choose between adherence to a diet; the Low FODMAP diet or endometriosis diet, or to contribute to the control group and not adhere to a diet. Women choosing to adhere to a diet were extensively guided by a dietician in training. In addition, both groups are asked to complete three questionnaires over a period of six months; once every two months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Low FODMAP diet | The Low FODMAP diet is an avoidance diet and consist of three phases. In the first phase, all nutrients high in FODMAPs (high-FODMAPS) are eliminated from the daily diet over a period of 2 to 6 weeks to calm down the bowel. The second phase consists of the addition of FODMAP challenges. During this phase the patient continues the Low FODMAP diet, but will reintroduce one high-FODMAP nutrient once every three days to see whether exposure to this high-FODMAP causes IBS symptoms. When this is not the case, the patient can continue eating this high-FODMAP group in their daily diet. In the third and final phase, the diet is fully personalized. This personalization is based on whether the patient tolerated the high-FODMAP nutrient or not during the FODMAP challenges. Only when the high-FODMAP nutrient is not tolerated, it is advised to permanently remove it from the daily diet. |
| OTHER | Endometriosis diet | The endometriosis diet The endometriosis diet is a patient experience based, avoidance diet developed by women diagnosed with endometriosis. Therefore no specific recommendations exist regarding the application of the endometriosis diet. With the endometriosis diet, women avoid nutrients they noticed provoked or aggravated their endometriosis-related symptoms such as red meat, coffee, sugar, lactose and soy. |
Timeline
- Start date
- 2021-04-01
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2023-02-06
- Last updated
- 2023-02-14
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05714189. Inclusion in this directory is not an endorsement.