How Did We Get Involved in A Medical Study?

In December of 2015, we were contacted by Dr. Gauree Konijeti, the Director of the Inflammatory Bowel Disease Program Division of Gastroenterology at Scripps Clinic in La Jolla, California. Dr. Konijeti told us that a patient with inflammatory bowel disease had introduced her to AIP and the patient’s improvement was so remarkable she was inspired to learn more. After further discussion Dr. Konijeti explained that she’d like to undertake a medical study of AIP to evaluate its potential efficacy for patients with Crohn’s and ulcerative colitis. She asked if Angie’s online group health coaching program, SAD to AIP in SIX, could be used to help the study participants transition to AIP. Our answer, of course, was, “YES, YES, YES!!”

Medical studies take lots of time, planning, and money to get off the ground. It wasn’t until September of 2016 that we were finally ready to get underway. Angie, joined by Amy Kubal, RD and Nicole Erickson, NTC, spent six weeks helping the participants, all of whom had Crohn’s or ulcerative colitis, slowly work their way through eliminations until they reached the full AIP elimination phase and then spent another five weeks in a maintenance phase. During the process, just like in SAD to AIP in SIX, the participants were introduced to important lifestyle changes too (like sleep, stress management, movement, and support).

We waited another year for all the results to be calculated and the study be published, but now they are ready to be shared!

What Were the Results?

Let’s just cut to the chase and look at the best line in the whole publication!

“Clinical remission was achieved by week 6 by 11/15 (73%) of study participants, and all 11 maintained clinical remission during the maintenance phase of the study. We did not hypothesize, that clinical remission would be achieved so early (week 6). Indeed, this proportion of participants with active IBD achieving clinical remission by week 6 rivals that of most drug therapies for IBD . . . (Konijeti, et al. 2017)”

YES, you read that correctly!

(There were 15 participants, nine with Crohn’s and six with ulcerative colitis.)

• By Week 6 (that was full AIP elimination), 11 of the 15 participants were in clinical remission (six with Crohn’s, five with ulcerative).
• All eleven participants maintained clinical remission through the maintenance phase.
• Seven of the 15 participants were on active biologic therapies but not in clinical remission at baseline, this suggests that diet can be an important component of successful treatment.
• Patients were advised no medication changes before study start, however one participant self-discontinued oral biologic therapy but still achieved clinical remission by week 6.
• Another participant self-discontinued oral biologic therapy, but continued biologic suppository and still achieved clinical remission.
• Two of the participants were able to discontinue steroid therapy.

To learn in-depth about the study methods, measures, analysis, and results, you can access the full article here.

What Does This Mean and What’s Next?

“It’s woooorking!”

That’s a little thing Angie usually says to the members of SAD to AIP in SIX, when they start to report health improvements. Sometimes at the beginning they aren’t quite sure it will work and when the first health improvements pop-up they are often uncertain the dietary and lifestyle changes could actually be the cause. That line is meant to be a humorous nudge about having confidence in the body’s response. In the future, we might be able to inspire confidence more easily with study results like this!

These results help the community put data behind our conviction that this process is benefiting so many of us. More importantly, it opens the door for big conversations with the medical community and massive changes in the standard of care for those with autoimmune disease. It’s our hope that the experience of Dr. Konijeti and her initial patient describing AIP inspires all of you to speak up at your medical appointments. We may be surprised how many more forward-thinkers exist!

Our fingers are crossed that the future will hold more research. The opportunity to duplicate the process with other kinds of autoimmune diagnoses is top of our wish list at Autoimmune Wellness! We also hope Dr. Konijeti and other researchers like her will have the chance to conduct larger studies and address any limitations encountered by this first study. Again, it is our voices and support of the organizations funding this research that can help this become a reality.

And for those of you wondering, yes, Angie was tempted to tell the research team when results started coming in,

“I told you . . . it’s woooorking!”