Efficacy Of The Autoimmune Protocol Diet For Inflammatory Bowel Disease
Notes for this study:
||Mean FC was elevated at baseline decreased from baseline to week 11, but the results were not statistically significant.
|Number of Subjects
||18-29, 30-44, 45-64
In this open-label, uncontrolled pilot study, 18 adults with active ulcerative colitis (UC) or Crohn's disease (CD) followed a 6-week elimination phase followed by a 5-week maintenance phase (during which no foods were reintroduced.) Participants recieved two books about the AIP before the study began, and recieved guidance from a certified health coach and a registered dietitian. Participants completed dietary records and the SIBDQ quality of life assessment.
Funding issues for this study:
The primary outcome was the proportion of patients achieving clinical remission at 11 weeks. Secondary outcomes included achievement of clinical outcome measures at week 6, changes in markers of disease activity (endoscopy, CRP, and FC) at weeks 6 and 11, changes in steroid use, and any adverse events.
Three participants withdrew before the study started, so 9 participants with CD and 6 with UC completed the first six weeks of the study; two more with CD were lost or withdrew by week 11. Clinical remission was achieved at week 6 by 6/9 participants with CD and 5/6 with UC. All 11 maintained clinical remission during the maintenance phase.
At baseline. CRP was elevated in 33% of participants and mean FC was also elevated. Mean FC and CRP scores decreased from baseline to week 11, but the results were not statistically significant, nor were there any significant differences in participant bodyweight or blood markers. Endoscopies indicated improvements in both CD and UC, but these findings were not analyzed for statistical significance. Two of three participants were able to discontinue steroids and one of these still achieved clinical remission. Two participants with CD developed worsening disease or bowel obstruction.
Notably, only 66.7% of the participants adhered to the protocol.
One author previously received honoraria from AbbVie, Janssen, Pfizer, and Takeda. Another author received research support from, and previously consulted for, Nestle Health Science.