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On April 28, 2022, the Peggy Lillis Foundation for C. diff Education and Advocacy sent an open letter, cosigned by Alliance for Aging Research, the Amputee Coalition, the Antibiotic Resistance Action Center, the Infectious Disease Society of America, NTM Info & Research, OpenBiome, the Partnership to Fight Infectious Disease, and the Sepsis Alliance to the Food and Drug Administration (FDA). The letter requests consideration by the agency for several critical aspects of the patient experience in order to improve processes for approving novel treatments for C. difficile infections (CDIs) that adequately address patient needs.
No new treatments for CDI have been approved since 2011. FDA has approved fecal microbiota transplants (FMTs) through enforcement discretion (a designation allowing physicians to prescribe the procedure at their discretion after acquiring informed consent), but access is still severely limited both in terms of insurance coverage and the availability of stool donors and facilities or providers to administer FMTs. Furthermore, endpoints in clinical trials of new CDI treatments do not often accurately or comprehensively reflect patient needs or the scope of CDI or rCDI.
In our letter, we have asked FDA to consider these key questions in their regulatory actions:
- What are the best endpoints for trials of treatments for CDI and rCDI?
- What are the socio-emotional impacts of rCDI?
- What are the societal implications of using broad-spectrum antibiotics where narrow-spectrum ones are available? How do we “cost” that in a consumer-based healthcare system?
As advocates for those who have suffered as a result of C. diff, it is our belief that FDA guidance and policy paradigms should be shifted to address both the unmet needs of CDI patients and the needs of the population at large in the face of antimicrobial resistance. Read the full letter here.
Less than two weeks ago I was diagnosed with C.Diff. It is my second occurrence this year. This occurrence was 8 weeks after my prior one which hadn’t been diagnosed at the time. Everything detailed in the April letter to the FDA and what I am reading on this blog is exactly what I am experiencing. I had no idea this disease existed until 2 weeks ago! I found this site while searching for any information on this bacteria.
Looking back, I believe my first episode of C.Diff was September, 2004. Previous to it, I had a difficult hysterectomy and treated with an antibiotic. Perhaps that was that surgery that was the catalyst for the C.Diff infection. I remember my doctor telling me that I now had a very bad internal bacterial infection. I remember her telling me it was an overgrowth of bacteria, but I don’t remember the name.
She treated me with an antibiotic called Tinidazole. She told me to keep the prescription name because not many doctors knew about it. I believe it was a new antibiotic in 2004 because a pharmacy had to compound it for me. After that I had 2 more occurrences of the bacteria (2005 and 2007). Both of which were resolved with Tinidazole.
Then no occurrences for 15 years! I moved from CA to TX last year. Thank God I kept the name of that prescription! After 7 weeks of diarrhea this year I saw my new doctor, explained my history and requested the prescription for Tinidazole. After 5 days my diarrhea was gone!
About 8 weeks after that episode I got it again. I waited far too long before calling my regular doctor again because I was under the care of a Gastroenterologist who prescribed Balsalazide Disodium for ulcerative colitis. After 25 days of that medication, my condition was dire. My colon could not digest any food. I was dying.
In desperation I called my regular doctor of Internal Medicine and asked for Tinidazole again. Since it worked for the previous occurrence, she prescribed it again. A blood panel came back positive for C.Diff. My diarrhea stopped the next day and then over the following three days my colon expelled the bacteria and dead material. It felt like a miracle.
I am on my last day of Tinidazole and am feeling very fearful that the disease will return. I have lost weight and am very weak. I experience dizziness and confusion. I am 74 years old. After reading the letter to the FDA, I know that I am in the 100,000 who have rCDI. I am thinking that the perhaps the stress of my move from CA to TX could be what awaken this disease in me again. I can’t think of another reason because I have been healthy for so long.
I’m writing on this blog to tell you about Tinidazole. It is an antibiotic for parasites but it works for me for this bacterial disease. I don’t know why, but am hoping it can help someone else too.
I’m fearing another recurrence since this is my 2nd occurrence in the last 6 months. I bought Florastor and have read about some foods that can help restore my gut health.
Is there a specific diet I should be on? Do you have other suggestions that can help me? I appreciate any recommendations!
I am sincerely thankful for this website and for this blog. I thought I was alone in this, but now I now there are many sufferers. My heart hurts for all of you.