Some clinical study work has been completed focused on evaluating the benefit and patient mode of delivery preference with regard to enema vs. oral capsules in certain disease states. At a high level, it is assumed that the oral route is the most convenient and preferred route for patients.
The rectal route of administration does have some advantages for both the local and systemic delivery of drugs. However, there has been a general lack of research in this area of drug formulation when compared to other routes for gastrointestinal drug delivery.
A number of studies investigating the potential of rectal drug delivery for the treatment of chronic conditions exist, including diabetes (Matsumoto et al., 2017; Shi et al., 2019), serious infections (das Neves et al., 2013; Ham and Buckheit, 2017; Nunes et al., 2018), hypertension (Abou el Ela Ael et al., 2016), asthma (Shiohira et al., 2009), and cancer (Lo et al., 2013; Seo et al., 2013; Ye et al., 2016; Din et al., 2017). Results from these studies suggest there is a need for more understanding with regard to the biological interactions of rectal drug delivery in both adults and children, as well as continued innovations in rectal drug formulations. From a commercial development point of view, the complexity in the design and development of rectal dosage forms also needs to be minimized as much as possible, to create dosage forms that are able to be reproducibly prepared and characterized consistently.
FMT clinical researchers are studying the clinical benefits of FMT in many disease states such as Clostridium difficile infection, conditions associated with Irritable Bowel Disease (IBD), and Autism (ASD), they also look to determine if there are any clinical differences between rectal/colonoscopy and oral capsule delivery methods in terms of demonstrated benefit or preference.
In a randomized clinical study entitled “ Effect of Oral Capsule– vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection” published in JAMA 2017, researchers sought to shed light on the clinical question of whether the clinical efficacy of fecal microbiota transplantation (FMT) in treating recurrent Clostridium difficile infection (RCDI) depend on the route of delivery (oral capsules or colonoscopy)?
Reported study results: “In this noninferiority randomized clinical trial that included 116 adults with RCDI, the proportion without recurrence over 12 weeks was 96.2% after a single treatment in a group treated with oral capsules and in a group treated via colonoscopy, meeting the noninferiority margin of 15%.” These results suggest that FMT by oral capsules or colonoscopy is a very effective approach to treating RCDI.
With efficacy established, it was also important to understand patient preference in terms of mode of delivery. Scoring for patient perception and satisfaction was also measured. What they found was the following in terms of scoring – Participants most frequently characterized FMT as an “innovative treatment” (63% of patients), “natural remedy” (41%), and “unpleasant, gross, or disgusting” (30%). Factors reported most frequently to influence preference for FMT delivery method were effectiveness (91%), safety (62%), physician’s recommendation (45%), aesthetics (29%), and cost to health care system (18%). A total of 97% of study participants indicated they would undergo the assigned delivery method again. A significantly greater proportion of participants receiving capsules rated their experience as “not at all unpleasant” (66% vs 44% for the colonoscopy delivery).
At Novel Biome, Dr. Jason Klop, ND provides FMT treatment to patients with Autism (ASD). As part of the treatment protocol, patients are eligible to receive delivery of FMT either as a capsule or as an enema for the initial loading dose. Based on his experience, Dr. Klop observes that “most patients who are able to swallow capsules will choose this as a mode of delivery”. In his treatment experience, Dr. Klop finds capsules and enemas equal in terms of measured outcomes.
In conclusion, the oral route for delivery in a capsule format is the most convenient and preferred route for FMT administration. There are, however, circumstances where taking a capsule is not possible due to the difficulty some patients have in swallowing capsules. In these cases, the rectal route may represent a practical alternative and can be used to administer FMT for both local and systemic action.
Our focus at Novel Biome is in supporting autistic children who suffer from digestive symptoms and significant microbiome imbalance to restore their microbiome through FMT. You can learn more about our approach to treatment by going here.
Team Novel Biome